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equate nicotine

Nicotine Polacrilex · Gum, Chewing

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
equate nicotine
Generic name
Nicotine Polacrilex
Dosage form
Gum, Chewing
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Wal-Mart Stores Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
12
Packages
31
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Nicotine 2 mg/1 359817 View
Nicotine 4 mg/1 359817 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Gum, Chewing
Route of administration
Oral
Presentations
43

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cholinergic Nicotinic Agonist [EPC] EPC All 61 members
Nicotine [CS] CS All 61 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076789
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 16, 2004
Sponsor
L PERRIGO CO
Products on application
1
Submissions recorded
9
Products approved under application 076789.
Product Trade name Form Strength Ingredient Status TE Flags
076789-001 NICOTINE POLACRILEX GUM, CHEWING NICOTINE POLACRILEX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076789.
Type No. Action Status Date Review
Supplement 31 Labeling Approved March 15, 2024 Standard
Supplement 23 Labeling Approved April 17, 2017 Standard
Supplement 22 Labeling Approved April 15, 2015 Standard
Supplement 21 Labeling Approved November 29, 2012 Standard
Supplement 18 Labeling Approved August 30, 2011 —
Supplement 16 Labeling Approved June 17, 2010 —
Supplement 2 Labeling Approved August 15, 2005 —
Supplement 1 Labeling Approved July 15, 2005 —
Original application 1 Approved September 16, 2004 —

Review documents

  • 0 · Original application · May 9, 2007

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260827). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260827 HUMAN OTC DRUG · 20260715 HUMAN OTC DRUG · 20260303 HUMAN OTC DRUG · 20250515

Indications and Usage

openFDA Drug Labeling

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

Purpose Stop smoking aid

Dosage and Administration

openFDA Drug Labeling

Directions • 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.

Warnings 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 • 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 • using a non-nicotine stop smoking drug • Taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if • 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. 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).

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • 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

Stop use and ask a doctor if • 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)

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg nicotine)

Adverse event reports

Source: openFDA FAERS
60,672
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: NICOTINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
49035-029-29 49035-029 Wal-Mart Stores Inc 220 BLISTER PACK in 1 CARTON (49035-029-29) / 1 GUM, CHEWING in 1 BLISTER PACK April 23, 2020
49035-170-29 49035-170 Wal-Mart Stores Inc 220 BLISTER PACK in 1 CARTON (49035-170-29) / 1 GUM, CHEWING in 1 BLISTER PACK February 25, 2020
49035-206-20 49035-206 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-206-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-206-96 49035-206 Wal-Mart Stores Inc 170 BLISTER PACK in 1 CARTON (49035-206-96) / 1 GUM, CHEWING in 1 BLISTER PACK March 8, 2005
49035-309-78 49035-309 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-309-78) / 1 GUM, CHEWING in 1 BLISTER PACK March 25, 2020
49035-352-06 49035-352 Wal-Mart Stores Inc 160 BLISTER PACK in 1 CARTON (49035-352-06) / 1 GUM, CHEWING in 1 BLISTER PACK August 8, 2017
49035-352-20 49035-352 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-352-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-352-60 49035-352 Wal-Mart Stores Inc 20 BLISTER PACK in 1 CARTON (49035-352-60) / 1 GUM, CHEWING in 1 BLISTER PACK August 8, 2017
49035-352-78 49035-352 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-352-78) / 1 GUM, CHEWING in 1 BLISTER PACK October 14, 2008
49035-365-06 49035-365 Wal-Mart Stores Inc 160 BLISTER PACK in 1 CARTON (49035-365-06) / 1 GUM, CHEWING in 1 BLISTER PACK August 8, 2017
49035-365-20 49035-365 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-365-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-365-60 49035-365 Wal-Mart Stores Inc 20 BLISTER PACK in 1 CARTON (49035-365-60) / 1 GUM, CHEWING in 1 BLISTER PACK August 8, 2017
49035-365-78 49035-365 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-365-78) / 1 GUM, CHEWING in 1 BLISTER PACK October 4, 2011
49035-415-78 49035-415 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-415-78) / 1 GUM, CHEWING in 1 BLISTER PACK April 4, 2020
49035-422-20 49035-422 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-422-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-422-96 49035-422 Wal-Mart Stores Inc 170 BLISTER PACK in 1 CARTON (49035-422-96) / 1 GUM, CHEWING in 1 BLISTER PACK April 6, 2005
49035-442-06 49035-442 Wal-Mart Stores Inc 160 BLISTER PACK in 1 CARTON (49035-442-06) / 1 GUM, CHEWING in 1 BLISTER PACK August 8, 2017
49035-442-20 49035-442 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-442-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-442-60 49035-442 Wal-Mart Stores Inc 20 BLISTER PACK in 1 CARTON (49035-442-60) / 1 GUM, CHEWING in 1 BLISTER PACK August 8, 2017
49035-442-78 49035-442 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-442-78) / 1 GUM, CHEWING in 1 BLISTER PACK October 7, 2011
49035-456-06 49035-456 Wal-Mart Stores Inc 160 BLISTER PACK in 1 CARTON (49035-456-06) / 1 GUM, CHEWING in 1 BLISTER PACK October 11, 2008
49035-456-20 49035-456 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-456-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-456-60 49035-456 Wal-Mart Stores Inc 20 BLISTER PACK in 1 CARTON (49035-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK April 15, 2009
49035-456-78 49035-456 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK May 9, 2007
49035-532-20 49035-532 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-532-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-532-60 49035-532 Wal-Mart Stores Inc 20 BLISTER PACK in 1 CARTON (49035-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK April 15, 2009
49035-532-78 49035-532 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-532-78) / 1 GUM, CHEWING in 1 BLISTER PACK May 9, 2007
49035-854-06 49035-854 Wal-Mart Stores Inc 160 BLISTER PACK in 1 CARTON (49035-854-06) / 1 GUM, CHEWING in 1 BLISTER PACK August 10, 2017
49035-854-20 49035-854 Wal-Mart Stores Inc 200 BLISTER PACK in 1 CARTON (49035-854-20) / 1 GUM, CHEWING in 1 BLISTER PACK August 22, 2025
49035-854-60 49035-854 Wal-Mart Stores Inc 20 BLISTER PACK in 1 CARTON (49035-854-60) / 1 GUM, CHEWING in 1 BLISTER PACK September 26, 2017
49035-854-78 49035-854 Wal-Mart Stores Inc 100 BLISTER PACK in 1 CARTON (49035-854-78) / 1 GUM, CHEWING in 1 BLISTER PACK October 14, 2008
49035-029 49035-029 Wal-Mart Stores Inc — March 9, 2005
49035-170 49035-170 Wal-Mart Stores Inc — March 22, 2005
49035-206 49035-206 Wal-Mart Stores Inc — March 8, 2005
49035-309 49035-309 Wal-Mart Stores Inc — March 25, 2020
49035-352 49035-352 Wal-Mart Stores Inc — October 14, 2008
49035-365 49035-365 Wal-Mart Stores Inc — October 4, 2011
49035-415 49035-415 Wal-Mart Stores Inc — April 4, 2020
49035-422 49035-422 Wal-Mart Stores Inc — March 8, 2005
49035-442 49035-442 Wal-Mart Stores Inc — June 15, 1990
49035-456 49035-456 Wal-Mart Stores Inc — May 9, 2007
49035-532 49035-532 Wal-Mart Stores Inc — May 9, 2007
49035-854 49035-854 Wal-Mart Stores Inc — October 14, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.