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Nicotine Polacrilex, Original

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
Nicotine Polacrilex, Original
Generic name
Nicotine Polacrilex
Dosage form
Gum, Chewing
Route
Buccal
Marketing category
ANDA · ANDA
Labeler
Chain Drug Consortium, LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
76% 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
Buccal
Presentations
4

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
074507
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 15, 1999
Sponsor
P AND L
Products on application
1
Submissions recorded
21
Products approved under application 074507.
Product Trade name Form Strength Ingredient Status TE Flags
074507-001 NICOTINE POLACRILEX GUM, CHEWING NICOTINE POLACRILEX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 074507.
Type No. Action Status Date Review
Supplement 59 Labeling Approved April 17, 2017 Standard
Supplement 55 Labeling Approved April 30, 2015 Standard
Supplement 53 Labeling Approved January 28, 2013 Standard
Supplement 39 Labeling Approved March 2, 2009 —
Supplement 41 Labeling Approved July 23, 2007 —
Supplement 33 Labeling Approved March 8, 2007 —
Supplement 35 Labeling Approved December 8, 2006 —
Supplement 28 Labeling Approved May 25, 2004 —
Supplement 23 Labeling Approved June 10, 2003 —
Supplement 21 Manufacturing (CMC) Approved October 15, 2002 —
Supplement 20 Manufacturing (CMC) Approved October 15, 2002 —
Supplement 19 Manufacturing (CMC) Approved October 15, 2002 —
Supplement 18 Manufacturing (CMC) Approved October 15, 2002 —
Supplement 17 Labeling Approved April 30, 2002 —
Supplement 10 Manufacturing (CMC) Approved February 19, 2002 —
Supplement 5 Manufacturing (CMC) Approved August 8, 2001 —
Supplement 1 Manufacturing (CMC) Approved February 22, 2001 —
Supplement 4 Manufacturing (CMC) Approved January 22, 2001 —
Supplement 2 Manufacturing (CMC) Approved March 31, 2000 —
Supplement 3 Labeling Approved December 27, 1999 —
Original application 1 Approved March 15, 1999 —

Review documents

  • 0 · Original application · June 10, 2004
  • 0 · Original application · April 30, 2003
  • 0 · Original application · March 15, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250630). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250630

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 - 2 mg 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 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.

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

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) - 2 mg Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg Nicotine Polacrilex 4 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
68016-286-62 68016-286 Chain Drug Consortium, LLC 11 BLISTER PACK in 1 CARTON (68016-286-62) / 10 GUM, CHEWING in 1 BLISTER PACK July 1, 2013
68016-287-62 68016-287 Chain Drug Consortium, LLC 11 BLISTER PACK in 1 CARTON (68016-287-62) / 10 GUM, CHEWING in 1 BLISTER PACK June 1, 2013
68016-286 68016-286 Chain Drug Consortium, LLC — July 1, 2013
68016-287 68016-287 Chain Drug Consortium, LLC — June 1, 2013

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 · 10 sections on this page.