NICORETTE

Manufacturer: Haleon US Holdings LLC
Effective date: 2025-04-25
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:59:49

Label at a glance#

ProductNICORETTE

Active ingredientNICOTINE

Label structure13 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 cigarett...

Storage and handling

• each lozenge contains: sodium 17 mg • Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge • sugar alcohol content: 1 g mannitol per lozenge • store at 20 - 25°C (68 - 77°F) • keep vial 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 (nicotine)

Active ingredient (in each lozenge) (4 mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 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 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 17 mg
Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge
sugar alcohol content: 1 g mannitol per lozenge
store at 20 - 25°C (68 - 77°F)
keep vial tightly closed and protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, magnesium stearate, mannitol, natural peppermint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-569-1743

Additional Information

SPL UNCLASSIFIED SECTION

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 printed inner safety seal under cap is broken or missing.

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 program as directed in the enclosed User’s Guide.

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

QuitTube^®

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0635-01

NICORETTE

nicotine polacrilex lozenge, 2 mg

stop smoking aid

Lozenge

2 mg

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 Nicorette 4 mg Lozenge.

72 LOZENGES, 2 mg EACH

(3 QuitTube^® Containers of 24)

Includes User’s Guide

ACTUAL SIZE

Mint

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0636-01

NICORETTE

nicotine polacrilex lozenge, 4 mg

stop smoking aid

Lozenge

4 mg

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 Nicorette 2 mg Lozenge.

72 LOZENGES, 4 mg EACH

(3 QuitTube^® Containers of 24)

Includes User’s Guide

ACTUAL SIZE

Mint

DailyMed RxNorm Mappings#

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

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
0135-0635-01	2024-01-30	C162847	48780-1	1030e365-0a11-111a-e063-dadaa90a10e2	Drug Facts
0135-0635-02	2024-01-30	C162847	48780-1	1030e365-0a11-111a-e063-dadaa90a10e2	Drug Facts
0135-0636-01	2024-01-30	C162847	48780-1	1030e365-0a11-111a-e063-dadaa90a10e2	Drug Facts
0135-0636-02	2024-01-30	C162847	48780-1	1030e365-0a11-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0635-01	NICORETTE	3 in 1 CARTON	LOZENGE	3	4
0135-0635-01	NICORETTE	72 in 1 CONTAINER	LOZENGE	72	4
0135-0635-02	NICORETTE	6 in 1 CARTON	LOZENGE	6	4
0135-0635-02	NICORETTE	144 in 1 CONTAINER	LOZENGE	144	4
0135-0636-01	NICORETTE	3 in 1 CARTON	LOZENGE	3	4
0135-0636-01	NICORETTE	72 in 1 CONTAINER	LOZENGE	72	4
0135-0636-02	NICORETTE	6 in 1 CARTON	LOZENGE	6	4
0135-0636-02	NICORETTE	144 in 1 CONTAINER	LOZENGE	144	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0635	NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]	4	Current NDC, 4 package rows	20250427_ffeb8286-860d-49f5-8df3-724afb4aaad8.zip
0135-0636	NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]	4	Current NDC, 4 package rows	20250427_ffeb8286-860d-49f5-8df3-724afb4aaad8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0635-01	EA - Each	0135-0635	10eeda6e-2d5e-482d-873e-08ff9b8cc94a	1	2025-07-08
0135-0635-02	EA - Each	0135-0635	218eb7cb-b8c8-4e69-9279-995c60b814ea	1	2023-12-05
0135-0636-01	EA - Each	0135-0636	2559d580-cc20-4a31-8c4f-4820b876157d	1	2025-06-13
0135-0636-02	EA - Each	0135-0636	669ddc97-8cce-44ec-ac83-413549152397	1	2025-07-08

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NICORETTE
nicotine polacrilex
NICOTINE
POLACRILIN
ASPARTAME
MAGNESIUM STEARATE
MANNITOL
POTASSIUM BICARBONATE
SODIUM ALGINATE
SODIUM CARBONATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0135-0635	0135-0635-01, 0135-0635-02
0135-0636	0135-0636-01, 0135-0636-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NICOTINE	6M3C89ZY6R	ACTIB
POLACRILIN	RCZ785HI7S	IACT
ASPARTAME	Z0H242BBR1	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POTASSIUM BICARBONATE	HM5Z15LEBN	IACT
SODIUM ALGINATE	C269C4G2ZQ	IACT
SODIUM CARBONATE	45P3261C7T	IACT
XANTHAN GUM	TTV12P4NEE	IACT
NICOTINE	6M3C89ZY6R	ACTIB
POLACRILIN	RCZ785HI7S	IACT
ASPARTAME	Z0H242BBR1	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POTASSIUM BICARBONATE	HM5Z15LEBN	IACT
SODIUM ALGINATE	C269C4G2ZQ	IACT
SODIUM CARBONATE	45P3261C7T	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

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 43.

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
A077007-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31
A077007-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`

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	ffeb8286-860d-49f5-8df3-724afb4aaad8	2025-04-25	Warnings	Exact identifier ndc (package): 0135-0636-01 ndc (package): 0135-0636-02 ndc (package): 0135-0635-02 ndc (package): 0135-0635-01 ndc (product): 0135-0635 ndc (product): 0135-0636 ndc11 (package): 00135063601 ndc11 (package): 00135063502 ndc11 (package): 00135063501 ndc11 (package): 00135063602 spl id: fd080df4-10ba-4b7e-a999-474f51610d2a spl set id: ffeb8286-860d-49f5-8df3-724afb4aaad8

Reported adverse events (FAERS/openFDA)#

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