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Nicotine Transdermal System

Nicotine · Film, Extended Release

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 Transdermal System
Generic name
Nicotine
Dosage form
Film, Extended Release
Route
Transdermal
Marketing category
ANDA · ANDA
Labeler
EXELAN PHARMACEUTICALS, INC.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
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 14 mg/24h 359817 View
Nicotine 21 mg/24h 359817 View
Nicotine 7 mg/24h 359817 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Film, Extended Release
Route of administration
Transdermal
Presentations
6

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
074612
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 20, 1997
Sponsor
DIFGEN PHARMS
Products on application
3
Submissions recorded
11
Products approved under application 074612.
Product Trade name Form Strength Ingredient Status TE Flags
074612-001 NICOTINE FILM, EXTENDED RELEASE NICOTINE Over-the-counter —
074612-002 NICOTINE FILM, EXTENDED RELEASE NICOTINE Over-the-counter —
074612-003 NICOTINE FILM, EXTENDED RELEASE NICOTINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 074612.
Type No. Action Status Date Review
Supplement 25 Labeling Approved April 13, 2015 Standard
Supplement 16 Labeling Approved February 16, 2010 —
Supplement 7 Labeling Approved October 30, 2007 —
Supplement 8 Manufacturing (CMC) Approved February 27, 2002 —
Supplement 6 Manufacturing (CMC) Approved February 15, 2000 —
Supplement 5 Manufacturing (CMC) Approved February 15, 2000 —
Supplement 4 Manufacturing (CMC) Approved May 24, 1999 —
Supplement 3 Manufacturing (CMC) Approved May 24, 1999 —
Supplement 2 Manufacturing (CMC) Approved May 24, 1999 —
Supplement 1 Manufacturing (CMC) Approved May 24, 1999 —
Original application 1 Approved October 20, 1997 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250601). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250601

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 self-help guide for complete directions and other information begin using the patch on your quit day If you smoke more than 10 cigarettes per day , use the following schedule below: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 Step 1 Step 2 Step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks apply one new patch every 24 hours on skin that is dry, clean, and hairless remove backing from patch and immediately press onto skin. Hold for 10 seconds. wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each day if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours it is important to complete treatment. If you feel you need to use the patch 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 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. an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. 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. When using this product if you have vivid dreams or other sleep disturbances, remove the patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, 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. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for pouch disposal. Dispose of the used patches by folding sticky end together and putting in pouch.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have 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. an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. stomach ulcer or diabetes history of seizures

Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, 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 patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 7 mg delivered over 24 hours

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
76282-781-40 76282-781 EXELAN PHARMACEUTICALS, INC. 14 POUCH in 1 CARTON (76282-781-40) / 1 h in 1 POUCH October 13, 2025
76282-782-40 76282-782 EXELAN PHARMACEUTICALS, INC. 14 POUCH in 1 CARTON (76282-782-40) / 1 h in 1 POUCH October 13, 2025
76282-783-40 76282-783 EXELAN PHARMACEUTICALS, INC. 14 POUCH in 1 CARTON (76282-783-40) / 1 h in 1 POUCH October 13, 2025
76282-781 76282-781 EXELAN PHARMACEUTICALS, INC. — October 13, 2025
76282-782 76282-782 EXELAN PHARMACEUTICALS, INC. — October 13, 2025
76282-783 76282-783 EXELAN PHARMACEUTICALS, INC. — October 13, 2025

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.