NICORETTE

Manufacturer: Haleon US Holdings LLC
Effective date: 2024-03-21
Label type: HUMAN OTC DRUG LABEL
Version: 20
Source: full-release
Hydrated at: 2026-06-01 00:10:09

Label at a glance#

ProductNICORETTE

Active ingredientNICOTINE

Label structure12 sections

Dosage and administration

if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more tha...

Storage and handling

each lozenge contains: sodium, 18 mg Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge store at 20 - 25°C (68 - 77°F) keep POPPAC tightly closed and protect from light

Contacts and useful links#

PhoneLabel contact1-888-569-1743

Websitewww.nicorette.com

www.Nicorette.com

Label contents#

Full prescribing information#

Active ingredient (in each lozenge) (2 mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge) (4 mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 4 mg

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.

Do not use (Mint)

OTC - DO NOT USE SECTION

if you are allergic to soya

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 your 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 problems occur
persistent indigestion or severe sore throat occurs
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

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it 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. No studies have been done to show if this product will work for you.
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the lozenge on your quit day
if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine lozenge
if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

nicotine lozenge is a medicine and must be used a certain way to get the best results
place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 - 30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
you may feel a warm or tingling sensation
occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 - 30 minutes)
do not eat or drink 15 minutes before using or while the lozenge is in your mouth
to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you.
before using this product, read the enclosed User’s Guide for complete directions and other important information
begin using the lozenge on your quit day
if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine lozenge
if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

nicotine lozenge is a medicine and must be used a certain way to get the best results
place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 - 30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
you may feel a warm or tingling sensation
occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 - 30 minutes)
do not eat or drink 15 minutes before using or while the lozenge is in your mouth
to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other information

STORAGE AND HANDLING SECTION

each lozenge contains:sodium, 18 mg
Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge
store at 20 - 25°C (68 - 77°F)
keep POPPAC tightly closed and protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, aspartame, calcium polycarbophil, corn syrup solids, flavors, lactose, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, triethyl citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-569-1743

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0510-07

Nicorette ^®

nicotine polacrilex lozenge, 2 mg

stop smoking aid

Lozenge

Includes User’s Guide

2mg

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 Lozenge

Mint

144 Lozenges,2 mg Each

(6 POPPAC ^®Containers of 24)

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

TAMPER EVIDENT FEATURE:Do not use if clear neckband printed “SEALED FOR SAFETY” is missing or broken.

Retain outer carton for full product uses, directions and warnings.

TO INCREASE YOUR SUCCESS IN QUITTING:

You must be motivated to quit.
Use Enough -Use at least 9 Nicorette ^® Lozenges per day during the first six weeks.
Use Long Enough -Use Nicorette ^® Lozenges for the full 12 weeks.
Use With a Support Programas directed in the enclosed User’s Guide.

Nicorette ^®POPPAC ^®

To open vial, push in child resistant band on the POPPAC ^®container with thumb.

Flip up the top of the POPPAC ^®and remove lozenge. A small amount of powder on opening of the POPPAC ^®is normal.

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.comor see inside for more details.

Trademarks are owned by or licensed to the GSK group of companies.

Distributed By:

GSKConsumer Healthcare

Warren, NJ 07059

Made in Switzerland

Made in the Switzerland

104959XC

Nicorette Lozenge Mint 2mg 144 count carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0511-07

Nicorette ^®

nicotine polacrilex lozenge, 4 mg

stop smoking aid

Lozenge

Includes User’s Guide

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 Lozenge

Mint

144 Lozenges,4 mg Each

(6 POPPAC ^®Containers of 24)

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

TAMPER EVIDENT FEATURE:Do not use if clear neckband printed “SEALED FOR SAFETY” is missing or broken.

Retain outer carton for full product uses, directions and warnings.

TO INCREASE YOUR SUCCESS IN QUITTING:

You must be motivated to quit.
Use Enough -Use at least 9 Nicorette ^® Lozenges per day during the first six weeks.
Use Long Enough -Use Nicorette ^® for the full 12 weeks.
Use With a Support Programas directed in the enclosed User’s Guide.

Nicorette ^®POPPAC ^®

To open vial, push in child resistant band on the POPPAC ^®container with thumb.

Flip up the top of the POPPAC ^®and remove lozenge. A small amount of powder on opening of the POPPAC ^®is normal.

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.comor see inside for more details.

Trademarks are owned by or licensed to the GSK group of companies.

Distributed By:

GSKConsumer Healthcare

Warren, NJ 07059

Made in the Switzerland

104960XC

Nicorette Lozenge Mint 4mg 144 count carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
968849	Nicorette 2 MG Oral Lozenge	PSN	20
968851	Nicorette 4 MG Oral Lozenge	PSN	20
359817	nicotine 2 MG Oral Lozenge	PSN	20
359818	nicotine 4 MG Oral Lozenge	PSN	20
968849	nicotine 2 MG Oral Lozenge [Nicorette]	SBD	20
968851	nicotine 4 MG Oral Lozenge [Nicorette]	SBD	20
359817	nicotine 2 MG Oral Lozenge	SCD	20
359818	nicotine 4 MG Oral Lozenge	SCD	20
968849	Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral Lozenge	SY	20
968849	Nicorette 2 MG Oral Lozenge	SY	20
968849	Nicorette 2 MG Troche	SY	20
968851	Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral Lozenge	SY	20
968851	Nicorette 4 MG Oral Lozenge	SY	20
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	20
359817	nicotine 2 MG Troche	SY	20
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	20
359818	nicotine 4 MG Troche	SY	20

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NICOTINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0135-0510-01	2020-11-16	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0510-06	2020-11-16	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0510-07	2020-11-16	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0511-01	2020-11-16	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0511-06	2020-11-16	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0511-07	2020-11-16	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0510-01	2020-01-31	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0510-06	2020-01-31	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0510-07	2020-01-31	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0511-01	2020-01-31	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0511-06	2020-01-31	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts
0135-0511-07	2020-01-31	C162847	48780-1	9d75b9d0-7564-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0510-01	NICORETTE	24 in 1 CONTAINER	LOZENGE	24	20
0135-0510-01	NICORETTE	3 in 1 CARTON	LOZENGE	3	20
0135-0510-06	NICORETTE	1 in 1 CARTON	LOZENGE	1	20
0135-0510-06	NICORETTE	24 in 1 CONTAINER	LOZENGE	24	20
0135-0510-07	NICORETTE	24 in 1 CONTAINER	LOZENGE	24	20
0135-0510-07	NICORETTE	6 in 1 CARTON	LOZENGE	6	20
0135-0511-01	NICORETTE	3 in 1 CARTON	LOZENGE	3	20
0135-0511-01	NICORETTE	24 in 1 CONTAINER	LOZENGE	24	20
0135-0511-06	NICORETTE	24 in 1 CONTAINER	LOZENGE	24	20
0135-0511-06	NICORETTE	1 in 1 CARTON	LOZENGE	1	20
0135-0511-07	NICORETTE	24 in 1 CONTAINER	LOZENGE	24	20
0135-0511-07	NICORETTE	6 in 1 CARTON	LOZENGE	6	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0510	NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]	20	Current NDC, Legacy NDC, 6 package rows	20240322_991704ed-781a-489b-8b56-0b558e8fc385.zip
0135-0511	NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]	20	Current NDC, Legacy NDC, 6 package rows	20240322_991704ed-781a-489b-8b56-0b558e8fc385.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0510-01	EA - Each	0135-0510	f0ffc1c3-e692-4905-aa88-2faaadb47531	1	2012-07-24
0135-0510-02	EA - Each	0135-0510	9ee598da-64eb-4003-8a5c-0d14031d6851	1	2012-07-24
0135-0510-03	EA - Each	0135-0510	54781fa4-261f-4ce0-a75f-73ff33635473	1	2014-05-02
0135-0510-05	EA - Each	0135-0510	5be5cc82-ba49-45eb-898e-05ba8dfcad33	1	2012-07-24
0135-0510-06	EA - Each	0135-0510	6b500f22-c3c2-40fb-af1c-142d8b79420d	1	2016-06-14
0135-0510-07	EA - Each	0135-0510	4a75b975-1405-40dc-883f-9d90afcdeb0f	1	2016-05-16
0135-0511-01	EA - Each	0135-0511	a15c6572-22c0-4827-ab60-2544221fea91	1	2012-07-24
0135-0511-02	EA - Each	0135-0511	19849702-0312-4cf2-b678-b2a3fc06e309	1	2012-07-24
0135-0511-05	EA - Each	0135-0511	40820f4d-e6eb-4d21-bf3a-9ad2abdee4a3	1	2012-07-24
0135-0511-06	EA - Each	0135-0511	71f603e6-7317-4301-8d67-4ad8760fa067	1	2016-06-14
0135-0511-07	EA - Each	0135-0511	bfceb1a7-9df3-4cd3-bce1-1221e7ab2a08	1	2016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	10
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	10
ACACIA	INACTIVE INGREDIENT	5C5403N26O	10
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	10
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	10
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	10
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	10
CALCIUM POLYCARBOPHIL	INACTIVE INGREDIENT	8F049NKY49	10
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	10
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	10
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	10
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	10
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	10
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	10
PALM KERNEL OIL	INACTIVE INGREDIENT	B0S90M0233	10
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	10
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	10
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	10
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	10
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	10
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	10
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	10

Products#

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

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

NICORETTE
nicotine polacrilex
POLACRILIN
ACACIA
ASPARTAME
CALCIUM POLYCARBOPHIL
CORN SYRUP
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MALTODEXTRIN
MANNITOL
POTASSIUM BICARBONATE
SODIUM ALGINATE
SODIUM CARBONATE
SOY PROTEIN
TRIETHYL CITRATE
XANTHAN GUM
NICOTINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0135-0510	0135-0510-01, 0135-0510-06, 0135-0510-07
0135-0511	0135-0511-01, 0135-0511-06, 0135-0511-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLACRILIN	RCZ785HI7S	IACT
ACACIA	5C5403N26O	IACT
ASPARTAME	Z0H242BBR1	IACT
CALCIUM POLYCARBOPHIL	8F049NKY49	IACT
CORN SYRUP	9G5L16BK6N	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MANNITOL	3OWL53L36A	IACT
POTASSIUM BICARBONATE	HM5Z15LEBN	IACT
SODIUM ALGINATE	C269C4G2ZQ	IACT
SODIUM CARBONATE	45P3261C7T	IACT
SOY PROTEIN	R44IWB3RN5	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
XANTHAN GUM	TTV12P4NEE	IACT
NICOTINE	6M3C89ZY6R	ACTIB
POLACRILIN	RCZ785HI7S	IACT
ACACIA	5C5403N26O	IACT
ASPARTAME	Z0H242BBR1	IACT
CALCIUM POLYCARBOPHIL	8F049NKY49	IACT
CORN SYRUP	9G5L16BK6N	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MANNITOL	3OWL53L36A	IACT
POTASSIUM BICARBONATE	HM5Z15LEBN	IACT
SODIUM ALGINATE	C269C4G2ZQ	IACT
SODIUM CARBONATE	45P3261C7T	IACT
SOY PROTEIN	R44IWB3RN5	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
XANTHAN GUM	TTV12P4NEE	IACT
NICOTINE	6M3C89ZY6R	ACTIB

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 11 · 632 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 144 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii+route 80 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, ORALLY DISINTEGRATING / ORAL		17 mg	Exact identifier — unii+route 144 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii+route 80 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 144 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	TABLET / ORAL	NA		Exact identifier — unii+route 16 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii+route 144 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 144 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii+route 144 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	TABLET / ORAL	14.07 mg		Exact identifier — unii+route 72 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, COATED PELLETS / ORAL		147 mg	Exact identifier — unii+route 144 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	LOZENGE / ORAL		120 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii+route 144 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii+route 144 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET / ORAL		52 mg	Exact identifier — unii+route 144 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	461P5CJN6T	SUSPENSION / ORAL		920 mg	Exact identifier — unii+route 16 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 144 equally ranked IID candidates
SODIUM ALGINATE	SODIUM ALGINATE	C269C4G2ZQ	LOZENGE / ORAL		1274 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 144 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 144 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	ELIXIR / ORAL	400 mg/1ml		Exact identifier — unii+route 72 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	LOZENGE / ORAL		20546 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii+route 80 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route 144 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	TABLET / ORAL	NA		Exact identifier — unii+route 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 80 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii+route 144 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	TABLET, COATED / ORAL	17 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, EXTENDED RELEASE / ORAL		129 mg	Exact identifier — unii+route 144 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii+route 48 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE PELLETS / ORAL		147 mg	Exact identifier — unii+route 144 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 144 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	CAPSULE, EXTENDED RELEASE / ORAL	28.5 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 144 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	TABLET / ORAL	NA		Exact identifier — unii+route 16 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii+route 80 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 144 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE / ORAL		10 mg	Exact identifier — unii+route 144 equally ranked IID candidates
CALCIUM POLYCARBOPHIL	CALCIUM POLYCARBOPHIL	8F049NKY49	LOZENGE / ORAL		480 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 144 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 144 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SYRUP / ORAL	600 mg		Exact identifier — unii+route 72 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	LOZENGE / ORAL		20546 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET / ORAL		52 mg	Exact identifier — unii+route 144 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	TROCHE / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii+route 48 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 144 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 144 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, EXTENDED RELEASE / ORAL		129 mg	Exact identifier — unii+route 144 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii+route 48 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	461P5CJN6T	CAPSULE / ORAL		107 mg	Exact identifier — unii+route 16 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	ELIXIR / ORAL	400 mg/1ml		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 144 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 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021330-001	NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL		RLD	2002-10-31
N021330-002	NICORETTE	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL		RLD, RS	2002-10-31

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021330-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2002-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021330-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2002-10-31	`4b0b4de00fa7…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	991704ed-781a-489b-8b56-0b558e8fc385	2024-03-21	Warnings	Exact identifier ndc (package): 0135-0511-01 ndc (package): 0135-0510-07 ndc (package): 0135-0511-06 ndc (package): 0135-0511-07 ndc (package): 0135-0510-01 ndc (package): 0135-0510-06 ndc (product): 0135-0510 ndc (product): 0135-0511 ndc11 (package): 00135051101 ndc11 (package): 00135051007 ndc11 (package): 00135051106 ndc11 (package): 00135051107 ndc11 (package): 00135051001 ndc11 (package): 00135051006 spl id: 142b2250-8264-423f-e063-6394a90ab05b spl set id: 991704ed-781a-489b-8b56-0b558e8fc385

Reported adverse events (FAERS/openFDA)#

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