Nicorelief

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2016-09-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:47:09

Label at a glance#

ProductNicorelief

Active ingredientNICOTINE

Label structure9 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 more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gu...

Storage and handling

• each piece contains: calcium 100 mg and sodium 11 mg • store at 20-25°C (68-77°F) • protect from light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-677-7858

Label contents#

Full prescribing information#

Active ingredient (in each chewing piece)

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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 right away (1-800-222-1222).

Directions

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 Nicotine Polacrilex Gum, 2 mg
if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg 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

STORAGE AND HANDLING SECTION

each piece contains: calcium 100 mg and sodium 11 mg
store at 20-25°C (68-77°F)
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, flavors, gum base, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc

Questions or comments?

OTC - QUESTIONS SECTION

call 1-866-677-7858

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of NICORETTE® GUM

NEW DIRECTIONS FOR USE

Keep Using if You Slip Up and Have a Cigarette

Use Beyond 12 Weeks if Needed to Quit

NICOrelief®

nicotine polacrilex gum, USP, 4 mg (nicotine)

Stop Smoking Aid

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 NICOrelief®, Nicotine Polacrilex Gum, 2 mg

mint flavor

4mg

50 Pieces

actual size

Includes User’s Guide

Free Audio CD upon request. See inside.image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
605820	NICOrelief 4 MG Chewing Gum	PSN	1
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	1
605820	nicotine 4 MG Chewing Gum [Nicorelief]	SBD	1
311975	nicotine 4 MG Chewing Gum	SCD	1
605820	Nicorelief 4 MG (nicotine polacrilex 22.2 MG) Chewing Gum	SY	1
605820	Nicorelief 4 MG Chewing Gum	SY	1
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 128	17856573401		NICORELIEF17856-5734-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
17856-5734-1	2020-01-31	C162847	48780-1	9d75b9d0-a582-f424-e053-dadaa90a57ce	Major Pharmaceuticals Nicorelief® Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-5734-1	Nicorelief	1 in 1 POUCH	GUM, CHEWING	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-5734	NICORELIEF (NICOTINE POLACRILEX) GUM, CHEWING [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 1 package rows	20160920_4d1b1bf9-e0ea-48de-a83c-daddbac3ea21.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5737-11	EA - Each	0904-5737	e01744dd-01c5-465f-bd66-c1368c29a8c6	1	2012-07-24
0904-5737-51	EA - Each	0904-5737	a2916fe9-b568-43cb-ad17-881f8e60b418	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Nicorelief
Nicotine Polacrilex
NICOTINE
POLACRILIN
ACESULFAME POTASSIUM
CALCIUM CARBONATE
CARNAUBA WAX
D&C YELLOW NO. 10
SODIUM BICARBONATE
SODIUM CARBONATE
SORBITOL
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-5734	17856-5734-1
0904-5737

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NICOTINE	6M3C89ZY6R	ACTIB
POLACRILIN	RCZ785HI7S	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
SODIUM CARBONATE	45P3261C7T	IACT
SORBITOL	506T60A25R	IACT
TALC	7SEV7J4R1U	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078326-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2006-10-30

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 · 43 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	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`f41ea6bd6efb…`

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
f3cb5faa-d29f-478b-9fbf-db98a920ed1e			4d1b1bf9-e0ea-48de-a83c-daddbac3ea21	2016-09-20	Warnings	Exact identifier spl id: f3cb5faa-d29f-478b-9fbf-db98a920ed1e spl set id: 4d1b1bf9-e0ea-48de-a83c-daddbac3ea21

Reported adverse events (FAERS/openFDA)#

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