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foster and thrive 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
foster and thrive nicotine
Generic name
Nicotine Polacrilex
Dosage form
Gum, Chewing
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Strategic Sourcing Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
8
Packages
10
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
18

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
206394
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 15, 2016
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
5
Products approved under application 206394.
Product Trade name Form Strength Ingredient Status TE Flags
206394-001 NICOTINE POLACRILEX GUM, CHEWING NICOTINE POLACRILEX Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206394.
Type No. Action Status Date Review
Supplement 14 Labeling Approved September 21, 2023 Standard
Supplement 13 Manufacturing (CMC) Approved January 6, 2022 Unknown
Supplement 9 Manufacturing (CMC) Approved April 24, 2020 —
Supplement 4 Manufacturing (CMC) Approved July 23, 2018 Unknown
Original application 1 Approved December 15, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260723). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260723 HUMAN OTC DRUG · 20260624

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 within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 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 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 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
70677-1164-1 70677-1164 Strategic Sourcing Services LLC 100 BLISTER PACK in 1 CARTON (70677-1164-1) / 1 GUM, CHEWING in 1 BLISTER PACK June 19, 2024
70677-1165-1 70677-1165 Strategic Sourcing Services LLC 100 BLISTER PACK in 1 CARTON (70677-1165-1) / 1 GUM, CHEWING in 1 BLISTER PACK June 27, 2024
70677-1166-1 70677-1166 Strategic Sourcing Services LLC 50 BLISTER PACK in 1 CARTON (70677-1166-1) / 1 GUM, CHEWING in 1 BLISTER PACK March 23, 2024
70677-1166-2 70677-1166 Strategic Sourcing Services LLC 110 BLISTER PACK in 1 CARTON (70677-1166-2) / 1 GUM, CHEWING in 1 BLISTER PACK March 23, 2024
70677-1167-1 70677-1167 Strategic Sourcing Services LLC 50 BLISTER PACK in 1 CARTON (70677-1167-1) / 1 GUM, CHEWING in 1 BLISTER PACK August 28, 2023
70677-1167-2 70677-1167 Strategic Sourcing Services LLC 110 BLISTER PACK in 1 CARTON (70677-1167-2) / 1 GUM, CHEWING in 1 BLISTER PACK August 28, 2023
70677-1170-1 70677-1170 Strategic Sourcing Services LLC 100 BLISTER PACK in 1 CARTON (70677-1170-1) / 1 GUM, CHEWING in 1 BLISTER PACK September 14, 2023
70677-1171-1 70677-1171 Strategic Sourcing Services LLC 100 BLISTER PACK in 1 CARTON (70677-1171-1) / 1 GUM, CHEWING in 1 BLISTER PACK April 20, 2024
70677-1192-1 70677-1192 Strategic Sourcing Services LLC 110 BLISTER PACK in 1 CARTON (70677-1192-1) / 1 GUM, CHEWING in 1 BLISTER PACK September 15, 2023
70677-1193-1 70677-1193 Strategic Sourcing Services LLC 110 BLISTER PACK in 1 CARTON (70677-1193-1) / 1 GUM, CHEWING in 1 BLISTER PACK August 28, 2023
70677-1164 70677-1164 Strategic Sourcing Services LLC — June 19, 2024
70677-1165 70677-1165 Strategic Sourcing Services LLC — June 27, 2024
70677-1166 70677-1166 Strategic Sourcing Services LLC — March 23, 2024
70677-1167 70677-1167 Strategic Sourcing Services LLC — August 28, 2023
70677-1170 70677-1170 Strategic Sourcing Services LLC — September 14, 2023
70677-1171 70677-1171 Strategic Sourcing Services LLC — April 20, 2024
70677-1192 70677-1192 Strategic Sourcing Services LLC — September 15, 2023
70677-1193 70677-1193 Strategic Sourcing Services LLC — August 28, 2023

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.