Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor

Manufacturer
Rugby Laboratories
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 01:48:02

Label at a glance#

ProductRugby Nicotine Polacrilex Gum, Coated Fruit Flavor
Active ingredientNICOTINE
Label structure20 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) - 2 mg

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex (equal to 2 mg nicotine)

Active ingredient (in each chewing piece) - 4 mg

OTC - ACTIVE INGREDIENT SECTION

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. 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 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 pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • using a non-nicotine stop smoking drug
  • taking 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
  • 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 (1-800-222-1222) 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 - 2 mg

SPL UNCLASSIFIED SECTION

  • each piece contains: calcium 115 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)
  • protect from light

Other information - 4 mg

SPL UNCLASSIFIED SECTION

  • each piece contains: calcium 115 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)
  • protect from light

Inactive ingredients - 2 mg

INACTIVE INGREDIENT SECTION

acacia, acesulfame potassium, carnauba wax, FD&C blue #2 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.

Inactive ingredients - 4 mg

INACTIVE INGREDIENT SECTION

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel 2 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to the active ingredient in Nicorette® Gum*

nicotine gum

nicotine polacrilex gum USP, 2 mg (nicotine)

stop smoking aid

2 mg

coated fruit flavor

sugar-free

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

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use nicotine Polacrilex Gum USP, 4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User's Guide.

  • 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 not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Package label 2 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY Sugar Free Nicotine Polacrilex Coated Fruit Flavor
RUGBY Sugar Free Nicotine Polacrilex Coated Fruit Flavor

Principal display panel 4 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to the active ingredient in Nicorette® Gum*

nicotine gum

nicotine polacrilex gum USP, 4 mg (nicotine)

stop smoking aid

4 mg

coated fruit flavor

sugar-free

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

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Gum USP, 2 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User's Guide.

  • 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 not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major- rugby.com 

Package label 4 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY Sugar Free Nicotine Polacrilex Coated Fruit Flavor
RUGBY Sugar Free Nicotine Polacrilex Coated Fruit Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN18
311975nicotine polacrilex 4 MG Chewing GumPSN18
314119nicotine 2 MG Chewing GumSCD18
311975nicotine 4 MG Chewing GumSCD18
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY18
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY18

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-3386-01Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-3386-01Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor10 in 1 CARTONGUM, CHEWING1018
0536-3386-37Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor4 in 1 CARTONGUM, CHEWING418
0536-3386-37Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-3387-01Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-3387-01Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor10 in 1 CARTONGUM, CHEWING1018
0536-3387-37Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-3387-37Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor4 in 1 CARTONGUM, CHEWING418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3386-01EA - Each0536-338612d1c942-9484-4a24-911a-cf7e7c405bac12013-02-13
0536-3386-37EA - Each0536-338638f86ab1-793d-40c8-87d0-30f472fdad0d12013-02-13
0536-3387-01EA - Each0536-33872461a3d4-7c2d-41b6-95ec-b07694591e4212013-02-13
0536-3387-37EA - Each0536-33873aa03a6e-593f-4191-8f3e-4b256f23783412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6R1
NICOTINEACTIVE MOIETY6M3C89ZY6R1
ACACIAINACTIVE INGREDIENT5C5403N26O1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71G1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7T1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-33860536-3386-37, 0536-3386-01
0536-33870536-3387-37, 0536-3387-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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 2 · 102 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GGUM, CHEWING / BUCCAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii+route
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / BUCCAL24 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / BUCCAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM CARBONATESODIUM CARBONATE45P3261C7TGUM, CHEWING / BUCCAL720 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
12 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / BUCCAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
12 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
12 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii+route
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
12 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM CARBONATESODIUM CARBONATE45P3261C7TGUM, CHEWING / BUCCAL720 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii+route
6 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GGUM, CHEWING / BUCCAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
12 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
12 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9GUM, CHEWING / BUCCAL147 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / BUCCAL24 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii+route
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM CARBONATESODIUM CARBONATE45P3261C7TGUM, CHEWING / BUCCAL720 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / BUCCAL0.01 mgExact identifier — unii+route
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GGUM, CHEWING / BUCCAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9GUM, CHEWING / BUCCAL147 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / BUCCAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM CARBONATESODIUM CARBONATE45P3261C7TGUM, CHEWING / BUCCAL720 mgExact identifier — unii+route+dosage form
6 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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079038-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08c2088c7a36db…
2026-09-14 22:38:342026-08A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-0884e616aacf4f…
2026-08-18 06:07:402026-07A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079038-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2009-07-083a93d1ddd44b…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079044-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08c2088c7a36db…
2026-09-14 22:38:342026-08A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0884e616aacf4f…
2026-08-18 06:07:402026-07A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079044-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083a93d1ddd44b…

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
Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNICOTINE POLACRILEXRugby Laboratoriesb973d045-7791-49c1-9216-4e0d511737352026-02-27WarningsExact identifier
ndc (package): 0536-3387-37
ndc (package): 0536-3386-37
ndc (package): 0536-3387-01
ndc (package): 0536-3386-01
ndc (product): 0536-3386
ndc (product): 0536-3387
ndc11 (package): 00536338601
ndc11 (package): 00536338637
ndc11 (package): 00536338737
ndc11 (package): 00536338701
spl id: c3233d63-7235-4d38-bea1-e0f2d0fe9cd1
spl set id: b973d045-7791-49c1-9216-4e0d51173735

Reported adverse events (FAERS/openFDA)#

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