FDA.reportPublic FDA data

Nicorette

Manufacturer
Haleon US Holdings LLC
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
27
Source
full-release
Hydrated at
2026-06-01 00:17:12

Label at a glance#

ProductNicorette White Ice Mint
Active ingredientNICOTINE
Label structure29 sections

Dosage and administration

if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following...

Label contents#

Full prescribing information#

Active ingredient (in each chewing piece)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex (equal to 2 mg nicotine)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

WARNINGS SECTION

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • a sodium-restricted diet
  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication. Nicotine can increase blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

Ask a doctor or a pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • using a non-nicotine stop smoking drug
  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • mouth, teeth or jaw problems occur
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
  • (For Cinnamon Surge)oral blistering occurs
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (2 mg)

DOSAGE & ADMINISTRATION SECTION

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the gum on your quit day
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine gum
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every 1 to 2 hours

1 piece every 2 to 4 hours

1 piece every 4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results
  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
  • repeat this process until most of the tingle is gone (about 30 minutes)
  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
  • do not use more than 24 pieces a day
  • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Directions (4 mg)

DOSAGE & ADMINISTRATION SECTION

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the gum on your quit day
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine gum
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every 1 to 2 hours

1 piece every 2 to 4 hours

1 piece every 4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results
  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
  • repeat this process until most of the tingle is gone (about 30 minutes)
  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
  • do not use more than 24 pieces a day
  • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider 

Other information (White Ice Mint)

SPL UNCLASSIFIED SECTION

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Original)

SPL UNCLASSIFIED SECTION

  • each piece contains:calcium 117 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Cinnamon Surge)

SPL UNCLASSIFIED SECTION

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Mint)

SPL UNCLASSIFIED SECTION

  • (2 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 14 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Spearmint Burst)

SPL UNCLASSIFIED SECTION

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Inactive ingredients (White Ice Mint)

INACTIVE INGREDIENT SECTION

each 2 mg piece contains:acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

each 4 mg piece contains:acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

Inactive ingredients (Original)

INACTIVE INGREDIENT SECTION

each 2 mg piece contains:flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol

each 4 mg piece contains:D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Inactive ingredients (Cinnamon Surge)

INACTIVE INGREDIENT SECTION

each 2 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains:acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive ingredients (Mint)

INACTIVE INGREDIENT SECTION

each 2 mg piece contains:acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

each 4 mg piece contains:acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive ingredients (Spearmint Burst)

INACTIVE INGREDIENT SECTION

each 2 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains:acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-569-1743

Additional information found on packaging

SPL UNCLASSIFIED SECTION

Includes Quit Support Program

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Use Enough– Chew at least 9 piecesof Nicorette gum per day during the first six weeks.
  3. Use Long Enough– Use Nicorette gum for the full 12 weeks.
  4. Use with a support programas directed in the enclosed User’s Guide.

To remove the gum, tear off single unit.

Peel off backing, starting at corner with loose edge.

Push gum through foil.

  • not for sale to those under 18 years of age
  • proof of age required
  • not for sale in vending machines or from any source where proof of age cannot be verified

This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.

Nicorette is proud to offer a free individualized quit support program! Visit www.quit.com/join-myquit for details.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0474-02 HALEON

NICORETTE

nicotine polacrilex gum, 2 mg stop smoking aid

Gum

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

COATED FOR BOLD FLAVOR

100 PIECES,2 mg EACH

White Ice Mint

824747 Front Label

824747 Nicorette White Ice Mint 2 mg_100 ct.jpg
824747 Nicorette White Ice Mint 2 mg_100 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0475-02 HALEON

NICORETTE

nicotine polacrilex gum, 4 mg stop smoking aid

Gum

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum.

COATED FOR BOLD FLAVOR

100 PIECES,4 mg EACH

White Ice Mint

824750 Front Label

824750 Nicorette White Ice Mint 4 mg_100 ct.jpg
824750 Nicorette White Ice Mint 4 mg_100 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0157-11 HALEON

NICORETTE

nicotine polacrilex gum, 2 mg stop smoking aid

Gum

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

200 PIECES,2 mg EACH

Original

824754 Front Label

824754 Nicorette Original Gum 2 mg_200 ct.jpg
824754 Nicorette Original Gum 2 mg_200 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0158-11 HALEON

NICORETTE

nicotine polacrilex gum, 4 mg stop smoking aid

Gum

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum.

200 PIECES, 4 mg EACH

Original

824757 Front Label

824757 Nicorette Original Gum 4 mg_200 ct.jpg
824757 Nicorette Original Gum 4 mg_200 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0466-02 HALEON

NICORETTE

nicotine polacrilex gum, 2 mg stop smoking aid

Gum

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

COATED FOR BOLD FLAVOR

100 PIECES

2 mg EACH

Cinnamon Surge

824735 Front Label

824735 Nicorette Cinnamon Surge 2 mg_100-new ct.jpg
824735 Nicorette Cinnamon Surge 2 mg_100-new ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0467-02 HALEON

NICORETTE

nicotine polacrilex gum, 4 mg stop smoking aid

Gum

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum.

COATED FOR BOLD FLAVOR

100 PIECES

4 mg EACH

Cinnamon Surge

824738 Front Label

824738 Nicorette Cinnamon Surge 4 mg_100 ct-new.jpg
824738 Nicorette Cinnamon Surge 4 mg_100 ct-new.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0229-05 HALEON

NICORETTE

nicotine polacrilex gum, 2 mg stop smoking aid

Gum

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

170 PIECES, 2 mg EACH

Mint

824762 Front Label

824762 Nicorette Mint 2 mg_170 ct.jpg
824762 Nicorette Mint 2 mg_170 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0230-05 HALEON

NICORETTE

nicotine polacrilex gum, 4 mg stop smoking aid

Gum

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

170 PIECES, 4 mg EACH

Mint

824763 Front Label

824763 Nicorette Mint 4 mg_170 ct.jpg
824763 Nicorette Mint 4 mg_170 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0532-02 HALEON

NICORETTE

nicotine polacrilex gum, 2 mg stop smoking aid

Gum

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

COATED FOR BOLD FLAVOR

100 PIECES, 2 mg EACH

Spearmint Burstwith a hint of chamomile

824758 Front Label

824758 Nicorette Spearmint Burst 2 mg_100 ct.jpg
824758 Nicorette Spearmint Burst 2 mg_100 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0533-02 HALEON

NICORETTE

nicotine polacrilex gum, 2 mg stop smoking aid

Gum

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 2 mg Gum

COATED FOR BOLD FLAVOR

100 PIECES, 4 mg EACH

Spearmint Burstwith a hint of chamomile

824760 Front Label

824760 Nicorette Spearmint Burst 4 mg_100 ct.jpg
824760 Nicorette Spearmint Burst 4 mg_100 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0355-03 HALEON

NICORETTE

nicotine polacrilex gum, 4 mg stop smoking aid

Gum

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

COATED FOR BOLD FLAVOR

160 PIECES, 4 mg EACH

Spearmint Burstwith a hint of chamomile

824761 Front Label

824761 Nicorette Spearmint Burst 4 mg_160 ct
824761 Nicorette Spearmint Burst 4 mg_160 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209326Nicorette 2 MG Chewing GumPSN27
105071Nicorette 4 MG Chewing GumPSN27
314119nicotine polacrilex 2 MG Chewing GumPSN27
311975nicotine polacrilex 4 MG Chewing GumPSN27
209326nicotine 2 MG Chewing Gum [Nicorette]SBD27
105071nicotine 4 MG Chewing Gum [Nicorette]SBD27
314119nicotine 2 MG Chewing GumSCD27
311975nicotine 4 MG Chewing GumSCD27
209326Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY27
209326Nicorette 2 MG Chewing GumSY27
105071Nicorette 4 MG Chewing GumSY27
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY27
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY27

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
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0135-0533-022024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-122024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-132024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-142024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0355-032020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-022020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-032020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-122020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-132020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-142020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-022020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-122020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-132020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-142020-11-16C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0355-032020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-022020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-032020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-122020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-132020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0532-142020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-022020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-122020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-132020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0533-142020-01-31C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0157-07NicoretteOriginal110 in 1 BLISTER PACKGUM, CHEWING11027
0135-0157-07NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0157-10NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0157-10NicoretteOriginal170 in 1 BLISTER PACKGUM, CHEWING17027
0135-0157-11NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0157-11NicoretteOriginal200 in 1 BLISTER PACKGUM, CHEWING20027
0135-0157-12NicoretteOriginal220 in 1 BLISTER PACKGUM, CHEWING22027
0135-0157-12NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0158-07NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0158-07NicoretteOriginal110 in 1 BLISTER PACKGUM, CHEWING11027
0135-0158-10NicoretteOriginal170 in 1 BLISTER PACKGUM, CHEWING17027
0135-0158-10NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0158-11NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0158-11NicoretteOriginal200 in 1 BLISTER PACKGUM, CHEWING20027
0135-0158-12NicoretteOriginal1 in 1 CARTONGUM, CHEWING127
0135-0158-12NicoretteOriginal220 in 1 BLISTER PACKGUM, CHEWING22027
0135-0229-03NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0229-03NicoretteMint50 in 1 BLISTER PACKGUM, CHEWING5027
0135-0229-04NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0229-04NicoretteMint110 in 1 BLISTER PACKGUM, CHEWING11027
0135-0229-05NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0229-05NicoretteMint170 in 1 BLISTER PACKGUM, CHEWING17027
0135-0230-03NicoretteMint50 in 1 BLISTER PACKGUM, CHEWING5027
0135-0230-03NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0230-04NicoretteMint110 in 1 BLISTER PACKGUM, CHEWING11027
0135-0230-04NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0230-05NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0230-05NicoretteMint170 in 1 BLISTER PACKGUM, CHEWING17027
0135-0355-03NicoretteSpearmint Burst16 in 1 CARTONGUM, CHEWING1627
0135-0355-03NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0466-01NicoretteCinnamon Surge20 in 1 BLISTER PACKGUM, CHEWING2027
0135-0466-01NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0466-02NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0466-02NicoretteCinnamon Surge100 in 1 BLISTER PACKGUM, CHEWING10027
0135-0466-03NicoretteCinnamon Surge190 in 1 BLISTER PACKGUM, CHEWING19027
0135-0466-03NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0466-05NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0466-05NicoretteCinnamon Surge160 in 1 BLISTER PACKGUM, CHEWING16027
0135-0466-07NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0466-07NicoretteCinnamon Surge40 in 1 BLISTER PACKGUM, CHEWING4027
0135-0466-08NicoretteCinnamon Surge20 in 1 CARTONGUM, CHEWING2027
0135-0466-14NicoretteCinnamon Surge25 in 1 CARTONGUM, CHEWING2527
0135-0467-01NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0467-01NicoretteCinnamon Surge20 in 1 BLISTER PACKGUM, CHEWING2027
0135-0467-02NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0467-02NicoretteCinnamon Surge100 in 1 BLISTER PACKGUM, CHEWING10027
0135-0467-05NicoretteCinnamon Surge160 in 1 BLISTER PACKGUM, CHEWING16027
0135-0467-05NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0467-07NicoretteCinnamon Surge40 in 1 BLISTER PACKGUM, CHEWING4027
0135-0467-07NicoretteCinnamon Surge1 in 1 CARTONGUM, CHEWING127
0135-0467-08NicoretteCinnamon Surge20 in 1 CARTONGUM, CHEWING2027
0135-0467-14NicoretteCinnamon Surge25 in 1 CARTONGUM, CHEWING2527
0135-0474-01NicoretteWhite Ice Mint20 in 1 BLISTER PACKGUM, CHEWING2027
0135-0474-01NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0474-02NicoretteWhite Ice Mint100 in 1 BLISTER PACKGUM, CHEWING10027
0135-0474-02NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0474-05NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0474-05NicoretteWhite Ice Mint160 in 1 BLISTER PACKGUM, CHEWING16027
0135-0474-08NicoretteWhite Ice Mint20 in 1 CARTONGUM, CHEWING2027
0135-0474-14NicoretteWhite Ice Mint25 in 1 CARTONGUM, CHEWING2527
0135-0474-15NicoretteWhite Ice Mint25 in 1 CARTONGUM, CHEWING2527
0135-0474-15NicoretteWhite Ice Mint8 in 1 PACKAGEGUM, CHEWING827
0135-0474-17NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0474-17NicoretteWhite Ice Mint10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0474-18NicoretteWhite Ice Mint10 in 1 CARTONGUM, CHEWING1027
0135-0474-18NicoretteWhite Ice Mint2 in 1 PACKAGEGUM, CHEWING227
0135-0474-19NicoretteWhite Ice Mint12 in 1 CARTONGUM, CHEWING1227
0135-0474-19NicoretteWhite Ice Mint10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0474-20NicoretteWhite Ice Mint18 in 1 CARTONGUM, CHEWING1827
0135-0474-20NicoretteWhite Ice Mint10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0475-01NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0475-01NicoretteWhite Ice Mint20 in 1 BLISTER PACKGUM, CHEWING2027
0135-0475-02NicoretteWhite Ice Mint100 in 1 BLISTER PACKGUM, CHEWING10027
0135-0475-02NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0475-03NicoretteWhite Ice Mint190 in 1 BLISTER PACKGUM, CHEWING19027
0135-0475-03NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0475-05NicoretteWhite Ice Mint160 in 1 BLISTER PACKGUM, CHEWING16027
0135-0475-05NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0475-08NicoretteWhite Ice Mint20 in 1 CARTONGUM, CHEWING2027
0135-0475-14NicoretteWhite Ice Mint25 in 1 CARTONGUM, CHEWING2527
0135-0475-15NicoretteWhite Ice Mint8 in 1 PACKAGEGUM, CHEWING827
0135-0475-15NicoretteWhite Ice Mint25 in 1 CARTONGUM, CHEWING2527
0135-0475-17NicoretteWhite Ice Mint10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0475-17NicoretteWhite Ice Mint1 in 1 CARTONGUM, CHEWING127
0135-0475-18NicoretteWhite Ice Mint10 in 1 CARTONGUM, CHEWING1027
0135-0475-18NicoretteWhite Ice Mint2 in 1 PACKAGEGUM, CHEWING227
0135-0475-19NicoretteWhite Ice Mint12 in 1 CARTONGUM, CHEWING1227
0135-0475-19NicoretteWhite Ice Mint10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0475-20NicoretteWhite Ice Mint10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0475-20NicoretteWhite Ice Mint18 in 1 CARTONGUM, CHEWING1827
0135-0532-02NicoretteSpearmint Burst10 in 1 CARTONGUM, CHEWING1027
0135-0532-02NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0532-03NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0532-03NicoretteSpearmint Burst16 in 1 CARTONGUM, CHEWING1627
0135-0532-12NicoretteSpearmint Burst10 in 1 CARTONGUM, CHEWING1027
0135-0532-12NicoretteSpearmint Burst2 in 1 PACKAGEGUM, CHEWING227
0135-0532-13NicoretteSpearmint Burst12 in 1 CARTONGUM, CHEWING1227
0135-0532-13NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0532-14NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0532-14NicoretteSpearmint Burst18 in 1 CARTONGUM, CHEWING1827
0135-0533-02NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0533-02NicoretteSpearmint Burst10 in 1 CARTONGUM, CHEWING1027
0135-0533-12NicoretteSpearmint Burst10 in 1 CARTONGUM, CHEWING1027
0135-0533-12NicoretteSpearmint Burst2 in 1 PACKAGEGUM, CHEWING227
0135-0533-13NicoretteSpearmint Burst12 in 1 CARTONGUM, CHEWING1227
0135-0533-13NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0533-14NicoretteSpearmint Burst10 in 1 BLISTER PACKGUM, CHEWING1027
0135-0533-14NicoretteSpearmint Burst18 in 1 CARTONGUM, CHEWING1827

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0157NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 8 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0158NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 8 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0229NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 6 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0230NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 6 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0355NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 2 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0466NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 12 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0467NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 10 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0474NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 18 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0475NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 20 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0532NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 10 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip
0135-0533NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 8 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0474-01EA - Each0135-04747355b978-4a0a-441a-b2ab-e565bcfc00f912014-09-03
0135-0474-02EA - Each0135-04742044d89f-3055-4242-8757-172ca504e4ef12012-07-24
0135-0474-03EA - Each0135-047406f52938-8d2e-4981-b92c-f538f94f201112012-07-24
0135-0474-05EA - Each0135-0474aa55c691-e610-4527-a246-1a14f67ba81a12013-02-13
0135-0474-08EA - Each0135-04741c2742b1-23e5-4f58-aa0d-f4c0dfc34e6412012-07-24
0135-0475-01EA - Each0135-047598f58aea-2368-4be2-a750-85b10c5590fa12014-09-03
0135-0475-02EA - Each0135-0475f38d7b7a-f356-4e58-bb4c-3f6fa1897ee312012-07-24
0135-0475-03EA - Each0135-0475e9e684d7-51e4-4ef2-a197-98a3c31b7ae812012-07-24
0135-0475-05EA - Each0135-0475d7822b4a-9894-47f8-8414-107b833403b212014-02-04
0135-0475-08EA - Each0135-047570574946-49c0-4c9d-b636-12fc3938723112012-07-24
0135-0157-07EA - Each0135-01570991b77e-fc04-456b-ab21-78c06fda96e512012-07-24
0135-0157-10EA - Each0135-01570434ed76-7d07-4be9-81f2-42af7709a71812012-07-24
0135-0157-11EA - Each0135-0157836511c2-0dd1-40b3-b2c3-a79af8a9055a12012-07-24
0135-0158-07EA - Each0135-0158a4fa6ae3-b7f1-4c4a-88ec-19b2352908a312012-07-24
0135-0158-10EA - Each0135-0158b12f60b1-8bc3-467c-ac6f-e5bc711395da12012-07-24
0135-0158-11EA - Each0135-015866f36b27-d1aa-4196-b0ff-d96868165edf12012-07-24
0135-0466-01EA - Each0135-046681f07711-d090-4210-a36a-faf7e69cce7212013-02-13
0135-0466-02EA - Each0135-046665a0a597-41cd-4666-841a-66c49705e61912012-07-24
0135-0466-03EA - Each0135-04668efb9208-cd20-43bd-b441-a6c028fece3e12015-10-02
0135-0466-05EA - Each0135-0466588b639e-b718-491d-91d1-fb3230fea66712014-02-04
0135-0466-08EA - Each0135-04661a504540-b381-4855-b852-e95a960585d412019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6R13
NICOTINEACTIVE MOIETY6M3C89ZY6R13
ACACIAINACTIVE INGREDIENT5C5403N26O13
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G913
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O693313
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ13
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G13
GLYCERININACTIVE INGREDIENTPDC6A3C0OX13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO13
LEVOMENTHOLINACTIVE INGREDIENTBZ1R15MTK713
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71G13
MENTHOLINACTIVE INGREDIENTL7T10EIP3A13
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2B13
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH13
POLACRILININACTIVE INGREDIENTRCZ785HI7S13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H13
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO13
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7T13
SORBITOLINACTIVE INGREDIENT506T60A25R13
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1N13
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD413
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP13
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-04740135-0474-01, 0135-0474-02, 0135-0474-05, 0135-0474-08, 0135-0474-14, 0135-0474-15, 0135-0474-17, 0135-0474-18, 0135-0474-19, 0135-0474-20
0135-04750135-0475-01, 0135-0475-02, 0135-0475-03, 0135-0475-05, 0135-0475-08, 0135-0475-14, 0135-0475-15, 0135-0475-17, 0135-0475-18, 0135-0475-19, 0135-0475-20
0135-01570135-0157-07, 0135-0157-10, 0135-0157-11, 0135-0157-12
0135-01580135-0158-07, 0135-0158-10, 0135-0158-11, 0135-0158-12
0135-04660135-0466-01, 0135-0466-02, 0135-0466-03, 0135-0466-05, 0135-0466-07, 0135-0466-08, 0135-0466-14
0135-04670135-0467-01, 0135-0467-02, 0135-0467-05, 0135-0467-07, 0135-0467-08, 0135-0467-14
0135-02290135-0229-03, 0135-0229-04, 0135-0229-05
0135-02300135-0230-03, 0135-0230-04, 0135-0230-05
0135-05320135-0532-02, 0135-0532-03, 0135-0532-12, 0135-0532-13, 0135-0532-14
0135-05330135-0533-02, 0135-0533-12, 0135-0533-13, 0135-0533-14
0135-03550135-0355-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 136 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLACRILINRCZ785HI7SIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM OXIDE3A3U0GI71GIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CARBONATE45P3261C7TIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
NICOTINE6M3C89ZY6RACTIB
POLACRILINRCZ785HI7SIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
CARNAUBA WAXR12CBM0EIZIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM OXIDE3A3U0GI71GIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM CARBONATE45P3261C7TIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
NICOTINE6M3C89ZY6RACTIB
POLACRILINRCZ785HI7SIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CARBONATE45P3261C7TIACT
SORBITOL506T60A25RIACT
NICOTINE6M3C89ZY6RACTIB
POLACRILINRCZ785HI7SIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CARBONATE45P3261C7TIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 222 · 13,317 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
1311 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii+route
1449 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii+route
1725 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii+dosage form
1449 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, EXTENDED RELEASE / ORAL25.74 mgExact identifier — unii+route
552 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE / ORAL20 mgExact identifier — unii+route
552 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii+route
1725 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GGUM, CHEWING / BUCCAL173 mgExact identifier — unii+dosage form
552 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
1449 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route
690 equally ranked IID candidates
ACACIAACACIA5C5403N26OSYRUP / ORALNAExact identifier — unii+route
1104 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route
1587 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route
1725 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii+route
966 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
1725 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route
1173 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
1104 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route
690 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route
552 equally ranked IID candidates
LEVOMENTHOLLEVOMENTHOLBZ1R15MTK7GUM, CHEWING / BUCCAL113 mgExact identifier — unii+dosage form
414 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
1449 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route
966 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii+route
1587 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET / ORAL0.09 mgExact identifier — unii+route
276 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii+route
1449 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii+route
1449 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route
1725 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii+route
1725 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route
1587 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii+route
1587 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii+route
1587 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii+route
1104 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii+dosage form
1104 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
1311 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii+route
1587 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii+route
966 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
966 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, CHEWABLE / ORAL2.1 mgExact identifier — unii+route
276 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
1449 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route
966 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii+route
1587 equally ranked IID candidates
LEVOMENTHOLLEVOMENTHOLBZ1R15MTK7TABLET / ORAL5 mgExact identifier — unii+route
414 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii+route
690 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii+route
1104 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii+route
1587 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
1725 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route
1173 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route
1104 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route
1587 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii+route
1449 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route
690 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
1311 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
1311 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii+dosage form
1587 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii+route
1587 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii+route
759 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii+route
1104 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii+route
690 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, EXTENDED RELEASE / ORAL25.74 mgExact identifier — unii+route
552 equally ranked IID candidates
POLACRILINPOLACRILINRCZ785HI7STABLET / ORAL3 mgExact identifier — unii+route
207 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 2 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018612-002NICORETTENICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09
N018612-003NICORETTE (MINT)NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23
N018612-004NICORETTENICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N018612-00283236832028-04-302013-01-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2584e616aacf4f…
2026-08-18 06:07:402026-07N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N018612-00283236832028-04-302013-01-0384e616aacf4f…
2026-08-18 06:07:402026-07N018612-00283236832028-04-302013-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018612-00283236832028-04-302013-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-00283236832028-04-302013-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N018612-00283236832028-04-302013-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-00283236832028-04-302013-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-00283236832028-04-302013-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-00283236832028-04-302013-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-00283236832028-04-302013-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-00283236832028-04-302013-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-00283236832028-04-302013-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018612-00283236832028-04-302013-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-00283236832028-04-302013-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018612-00283236832028-04-302013-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018612-00283236832028-04-302013-01-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018612-00283236832028-04-302013-01-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018612-00283236832028-04-302013-01-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018612-00283236832028-04-302013-01-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018612-00283236832028-04-302013-01-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018612-00283236832028-04-302013-01-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018612-00283236832028-04-302013-01-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018612-00283236832028-04-302013-01-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018612-00283236832028-04-302013-01-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N018612-00283236832028-04-302013-01-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018612-00283236832028-04-302013-01-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018612-00283236832028-04-302013-01-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018612-00283236832028-04-302013-01-033f01610625f2…
2019-09-15 20:21 UTC2019-09N018612-00283236832028-04-302013-01-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N018612-00283236832028-04-302013-01-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018612-00283236832028-04-302013-01-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018612-00283236832028-04-302013-01-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018612-00283236832028-04-302013-01-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018612-00283236832028-04-302013-01-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018612-00283236832028-04-302013-01-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018612-00283236832028-04-302013-01-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018612-00283236832028-04-302013-01-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N018612-00283236832028-04-302013-01-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N018612-00283236832028-04-302013-01-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018612-00283236832028-04-302013-01-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018612-00283236832028-04-302013-01-03f41ea6bd6efb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020066-002NICORETTENICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09
N020066-003NICORETTE (MINT)NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23
N020066-004NICORETTENICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N020066-00283236832028-04-30Drug product2013-01-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0984e616aacf4f…
2026-09-14 22:38:342026-08N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2384e616aacf4f…
2026-09-14 22:38:342026-08N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2584e616aacf4f…
2026-08-18 06:07:402026-07N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N020066-00283236832028-04-30Drug product2013-01-0384e616aacf4f…
2026-08-18 06:07:402026-07N020066-00283236832028-04-30Drug product2013-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020066-00283236832028-04-30Drug product2013-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-00283236832028-04-30Drug product2013-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020066-00283236832028-04-30Drug product2013-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-00283236832028-04-30Drug product2013-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-00283236832028-04-30Drug product2013-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-00283236832028-04-30Drug product2013-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-00283236832028-04-30Drug product2013-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-00283236832028-04-30Drug product2013-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-00283236832028-04-30Drug product2013-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020066-00283236832028-04-30Drug product2013-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-00283236832028-04-30Drug product2013-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020066-00283236832028-04-30Drug product2013-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020066-00283236832028-04-30Drug product2013-01-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020066-00283236832028-04-30Drug product2013-01-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020066-00283236832028-04-30Drug product2013-01-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020066-00283236832028-04-30Drug product2013-01-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020066-00283236832028-04-30Drug product2013-01-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020066-00283236832028-04-30Drug product2013-01-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020066-00283236832028-04-30Drug product2013-01-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020066-00283236832028-04-30Drug product2013-01-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020066-00283236832028-04-30Drug product2013-01-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N020066-00283236832028-04-30Drug product2013-01-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020066-00283236832028-04-30Drug product2013-01-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020066-00283236832028-04-30Drug product2013-01-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020066-00283236832028-04-30Drug product2013-01-033f01610625f2…
2019-09-15 20:21 UTC2019-09N020066-00283236832028-04-30Drug product2013-01-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N020066-00283236832028-04-30Drug product2013-01-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020066-00283236832028-04-30Drug product2013-01-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020066-00283236832028-04-30Drug product2013-01-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020066-00283236832028-04-30Drug product2013-01-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020066-00283236832028-04-30Drug product2013-01-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020066-00283236832028-04-30Drug product2013-01-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020066-00283236832028-04-30Drug product2013-01-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020066-00283236832028-04-30Drug product2013-01-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N020066-00283236832028-04-30Drug product2013-01-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N020066-00283236832028-04-30Drug product2013-01-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020066-00283236832028-04-30Drug product2013-01-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020066-00283236832028-04-30Drug product2013-01-03f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicorette OriginalNICOTINE POLACRILEXHaleon US Holdings LLC673fd19f-69b3-4f73-b9b4-18b5f4cbf69c2024-08-13WarningsExact identifier
ndc (package): 0135-0475-19
ndc (package): 0135-0466-02
ndc (package): 0135-0467-02
ndc (package): 0135-0230-04
ndc (package): 0135-0229-04
ndc (package): 0135-0533-02
ndc (package): 0135-0474-18
ndc (package): 0135-0475-18
ndc (package): 0135-0157-12
ndc (package): 0135-0532-02
ndc (package): 0135-0475-01
ndc (package): 0135-0467-05
ndc (package): 0135-0474-19
ndc (package): 0135-0158-11
ndc (package): 0135-0475-03
ndc (package): 0135-0475-05
ndc (package): 0135-0532-03
ndc (package): 0135-0467-08
ndc (package): 0135-0229-03
ndc (package): 0135-0466-07
ndc (package): 0135-0474-15
ndc (package): 0135-0532-12
ndc (package): 0135-0158-12
ndc (package): 0135-0157-11
ndc (package): 0135-0466-08
ndc (package): 0135-0466-05
ndc (package): 0135-0475-14
ndc (package): 0135-0157-10
ndc (package): 0135-0467-14
ndc (package): 0135-0474-02
ndc (package): 0135-0158-07
ndc (package): 0135-0475-15
ndc (package): 0135-0474-17
ndc (package): 0135-0475-02
ndc (package): 0135-0466-01
ndc (package): 0135-0467-07
ndc (package): 0135-0533-12
ndc (package): 0135-0475-20
ndc (package): 0135-0158-10
ndc (package): 0135-0230-03
ndc (package): 0135-0532-13
ndc (package): 0135-0355-03
ndc (package): 0135-0474-20
ndc (package): 0135-0532-14
ndc (package): 0135-0474-01
ndc (package): 0135-0474-08
ndc (package): 0135-0533-14
ndc (package): 0135-0157-07
ndc (package): 0135-0466-03
ndc (package): 0135-0466-14
ndc (package): 0135-0474-05
ndc (package): 0135-0475-08
ndc (package): 0135-0229-05
ndc (package): 0135-0474-14
ndc (package): 0135-0230-05
ndc (package): 0135-0533-13
ndc (package): 0135-0467-01
ndc (package): 0135-0475-17
ndc (product): 0135-0157
ndc (product): 0135-0533
ndc (product): 0135-0532
ndc (product): 0135-0467
ndc (product): 0135-0229
ndc (product): 0135-0158
ndc (product): 0135-0475
ndc (product): 0135-0474
ndc (product): 0135-0355
ndc (product): 0135-0466
ndc (product): 0135-0230
ndc11 (package): 00135015807
ndc11 (package): 00135023003
ndc11 (package): 00135053302
ndc11 (package): 00135022903
ndc11 (package): 00135047419
ndc11 (package): 00135046607
ndc11 (package): 00135046614
ndc11 (package): 00135053312
ndc11 (package): 00135015711
ndc11 (package): 00135022905
ndc11 (package): 00135053213
ndc11 (package): 00135053203
ndc11 (package): 00135047418
ndc11 (package): 00135046603
ndc11 (package): 00135047515
ndc11 (package): 00135015710
ndc11 (package): 00135047420
ndc11 (package): 00135047408
ndc11 (package): 00135047501
ndc11 (package): 00135053202
ndc11 (package): 00135047405
ndc11 (package): 00135053313
ndc11 (package): 00135047520
ndc11 (package): 00135047414
ndc11 (package): 00135053214
ndc11 (package): 00135046701
ndc11 (package): 00135053212
ndc11 (package): 00135015712
ndc11 (package): 00135047402
ndc11 (package): 00135046605
ndc11 (package): 00135047415
ndc11 (package): 00135047417
ndc11 (package): 00135047518
ndc11 (package): 00135035503
ndc11 (package): 00135046608
ndc11 (package): 00135047517
ndc11 (package): 00135015811
ndc11 (package): 00135047514
ndc11 (package): 00135022904
ndc11 (package): 00135047401
ndc11 (package): 00135015707
ndc11 (package): 00135046602
ndc11 (package): 00135047502
ndc11 (package): 00135047519
ndc11 (package): 00135023005
ndc11 (package): 00135047505
ndc11 (package): 00135046705
ndc11 (package): 00135015812
ndc11 (package): 00135053314
ndc11 (package): 00135046601
ndc11 (package): 00135046714
ndc11 (package): 00135046708
ndc11 (package): 00135047508
ndc11 (package): 00135046707
ndc11 (package): 00135015810
ndc11 (package): 00135047503
ndc11 (package): 00135023004
ndc11 (package): 00135046702
spl id: 1f929250-cbfa-d6eb-e063-6394a90a7281
spl set id: 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.