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Nicotine Transdermal System

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 Transdermal System
Dosage form
Patch, Extended Release
Route
Transdermal
Marketing category
ANDA · ANDA
Labeler
AmerisourceBergen Drug Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
28
Packages
42
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 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
Patch, Extended Release
Route of administration
Transdermal
Presentations
70

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 20260318). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260318 HUMAN OTC DRUG · 20260313 HUMAN OTC DRUG · 20250325

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 • to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures • 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 SECTION 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 this 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 patch disposal. • Dispose of the used patches by folding sticky ends 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 Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-7936 NDC: 50090-7936-0 24 h in a PATCH / 14 in a CARTON

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
50090-7936-0 50090-7936 A-S Medication Solutions 14 PATCH in 1 CARTON (50090-7936-0) / 24 h in 1 PATCH March 11, 2026
46122-352-74 46122-352 AmerisourceBergen Drug Corporation 14 POUCH in 1 CARTON (46122-352-74) / 1 h in 1 POUCH June 25, 2024
46122-353-74 46122-353 AmerisourceBergen Drug Corporation 14 POUCH in 1 CARTON (46122-353-74) / 1 h in 1 POUCH June 25, 2024
46122-354-74 46122-354 AmerisourceBergen Drug Corporation 14 POUCH in 1 CARTON (46122-354-74) / 1 h in 1 POUCH June 25, 2024
46122-568-03 46122-568 AmerisourceBergen Drug Corporation 28 POUCH in 1 CARTON (46122-568-03) / 1 h in 1 POUCH June 25, 2024
46122-568-07 46122-568 AmerisourceBergen Drug Corporation 7 POUCH in 1 CARTON (46122-568-07) / 1 h in 1 POUCH June 25, 2024
46122-831-45 46122-831 AmerisourceBergen Drug Corporation 14 PATCH in 1 CARTON (46122-831-45) / 24 h in 1 PATCH July 1, 2026
46122-832-45 46122-832 AmerisourceBergen Drug Corporation 14 PATCH in 1 CARTON (46122-832-45) / 24 h in 1 PATCH July 1, 2026
46122-833-45 46122-833 AmerisourceBergen Drug Corporation 14 PATCH in 1 CARTON (46122-833-45) / 24 h in 1 PATCH July 1, 2026
46122-833-75 46122-833 AmerisourceBergen Drug Corporation 28 PATCH in 1 CARTON (46122-833-75) / 24 h in 1 PATCH July 1, 2026
46122-833-76 46122-833 AmerisourceBergen Drug Corporation 7 PATCH in 1 CARTON (46122-833-76) / 24 h in 1 PATCH July 1, 2026
68001-432-88 68001-432 BluePoint Laboratories 7 POUCH in 1 CARTON (68001-432-88) / 1 h in 1 POUCH June 27, 2024
68001-432-90 68001-432 BluePoint Laboratories 14 POUCH in 1 CARTON (68001-432-90) / 1 h in 1 POUCH June 27, 2024
68001-433-88 68001-433 BluePoint Laboratories 7 POUCH in 1 CARTON (68001-433-88) / 1 h in 1 POUCH June 27, 2024
68001-433-90 68001-433 BluePoint Laboratories 14 POUCH in 1 CARTON (68001-433-90) / 1 h in 1 POUCH June 27, 2024
68001-434-88 68001-434 BluePoint Laboratories 7 POUCH in 1 CARTON (68001-434-88) / 1 h in 1 POUCH June 27, 2024
68001-434-90 68001-434 BluePoint Laboratories 14 POUCH in 1 CARTON (68001-434-90) / 1 h in 1 POUCH June 27, 2024
68001-434-91 68001-434 BluePoint Laboratories 28 POUCH in 1 CARTON (68001-434-91) / 1 h in 1 POUCH June 27, 2024
70000-0760-1 70000-0760 CARDINAL HEALTH 110, LLC. DBA LEADER 7 PATCH in 1 CARTON (70000-0760-1) / 24 h in 1 PATCH March 20, 2026
70000-0760-2 70000-0760 CARDINAL HEALTH 110, LLC. DBA LEADER 14 PATCH in 1 CARTON (70000-0760-2) / 24 h in 1 PATCH March 20, 2026
70000-0761-1 70000-0761 CARDINAL HEALTH 110, LLC. DBA LEADER 7 PATCH in 1 CARTON (70000-0761-1) / 24 h in 1 PATCH March 20, 2026
70000-0761-2 70000-0761 CARDINAL HEALTH 110, LLC. DBA LEADER 14 PATCH in 1 CARTON (70000-0761-2) / 24 h in 1 PATCH March 20, 2026
70000-0762-1 70000-0762 CARDINAL HEALTH 110, LLC. DBA LEADER 7 PATCH in 1 CARTON (70000-0762-1) / 24 h in 1 PATCH March 20, 2026
70000-0762-2 70000-0762 CARDINAL HEALTH 110, LLC. DBA LEADER 14 PATCH in 1 CARTON (70000-0762-2) / 24 h in 1 PATCH March 20, 2026
70000-0510-1 70000-0510 Cardinal Health 7 POUCH in 1 CARTON (70000-0510-1) / 1 h in 1 POUCH September 1, 2024
70000-0510-2 70000-0510 Cardinal Health 14 POUCH in 1 CARTON (70000-0510-2) / 1 h in 1 POUCH September 1, 2024
70000-0511-1 70000-0511 Cardinal Health 7 POUCH in 1 CARTON (70000-0511-1) / 1 h in 1 POUCH September 1, 2024
70000-0511-2 70000-0511 Cardinal Health 14 POUCH in 1 CARTON (70000-0511-2) / 1 h in 1 POUCH September 1, 2024
70000-0512-1 70000-0512 Cardinal Health 7 POUCH in 1 CARTON (70000-0512-1) / 1 h in 1 POUCH September 1, 2024
70000-0512-2 70000-0512 Cardinal Health 14 POUCH in 1 CARTON (70000-0512-2) / 1 h in 1 POUCH September 1, 2024
37808-460-01 37808-460 H-E-B 14 POUCH in 1 CARTON (37808-460-01) / 1 h in 1 POUCH June 25, 2024
37808-461-01 37808-461 H-E-B 14 POUCH in 1 CARTON (37808-461-01) / 1 h in 1 POUCH June 25, 2024
36800-032-14 36800-032 Topco Associates LLC 14 POUCH in 1 CARTON (36800-032-14) / 1 h in 1 POUCH June 25, 2024
36800-034-14 36800-034 Topco Associates LLC 14 POUCH in 1 CARTON (36800-034-14) / 1 h in 1 POUCH June 25, 2024
36800-038-14 36800-038 Topco Associates LLC 14 POUCH in 1 CARTON (36800-038-14) / 1 h in 1 POUCH June 25, 2024
76162-740-14 76162-740 Topco Associates LLC 14 PATCH in 1 CARTON (76162-740-14) / 24 h in 1 PATCH September 1, 2026
76162-741-14 76162-741 Topco Associates LLC 14 PATCH in 1 CARTON (76162-741-14) / 24 h in 1 PATCH September 1, 2026
76162-742-14 76162-742 Topco Associates LLC 14 PATCH in 1 CARTON (76162-742-14) / 24 h in 1 PATCH September 1, 2026
0363-1243-01 0363-1243 Walgreens 14 POUCH in 1 CARTON (0363-1243-01) / 1 h in 1 POUCH September 30, 2024
0363-1244-01 0363-1244 Walgreens 14 POUCH in 1 CARTON (0363-1244-01) / 1 h in 1 POUCH September 30, 2024
0363-1245-01 0363-1245 Walgreens 14 POUCH in 1 CARTON (0363-1245-01) / 1 h in 1 POUCH September 30, 2024
0363-1245-02 0363-1245 Walgreens 7 POUCH in 1 CARTON (0363-1245-02) / 1 h in 1 POUCH September 30, 2024
50090-7936 50090-7936 A-S Medication Solutions — May 14, 2015
46122-352 46122-352 AmerisourceBergen Drug Corporation — June 25, 2024
46122-353 46122-353 AmerisourceBergen Drug Corporation — June 25, 2024
46122-354 46122-354 AmerisourceBergen Drug Corporation — June 25, 2024
46122-568 46122-568 AmerisourceBergen Drug Corporation — June 25, 2024
46122-831 46122-831 AmerisourceBergen Drug Corporation — July 1, 2026
46122-832 46122-832 AmerisourceBergen Drug Corporation — July 1, 2026
46122-833 46122-833 AmerisourceBergen Drug Corporation — July 1, 2026
68001-432 68001-432 BluePoint Laboratories — June 27, 2024
68001-433 68001-433 BluePoint Laboratories — June 27, 2024
68001-434 68001-434 BluePoint Laboratories — June 27, 2024
70000-0760 70000-0760 CARDINAL HEALTH 110, LLC. DBA LEADER — March 20, 2026
70000-0761 70000-0761 CARDINAL HEALTH 110, LLC. DBA LEADER — March 20, 2026
70000-0762 70000-0762 CARDINAL HEALTH 110, LLC. DBA LEADER — March 20, 2026
70000-0510 70000-0510 Cardinal Health — September 1, 2024
70000-0511 70000-0511 Cardinal Health — September 1, 2024
70000-0512 70000-0512 Cardinal Health — September 1, 2024
37808-460 37808-460 H-E-B — June 25, 2024
37808-461 37808-461 H-E-B — June 25, 2024
36800-032 36800-032 Topco Associates LLC — June 25, 2024
36800-034 36800-034 Topco Associates LLC — June 25, 2024
36800-038 36800-038 Topco Associates LLC — June 25, 2024
76162-740 76162-740 Topco Associates LLC — September 1, 2026
76162-741 76162-741 Topco Associates LLC — September 1, 2026
76162-742 76162-742 Topco Associates LLC — September 1, 2026
0363-1243 0363-1243 Walgreens — September 30, 2024
0363-1244 0363-1244 Walgreens — September 30, 2024
0363-1245 0363-1245 Walgreens — September 30, 2024

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.