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Nicotine

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
Generic name
Nicotine
Dosage form
Patch
Route
Transdermal
Marketing category
ANDA · ANDA
Labeler
Rugby Laboratories
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
10
Packages
15
Data completeness
83% 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
Route of administration
Transdermal
Presentations
25

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 20260122). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260122 HUMAN OTC DRUG · 20250730 HUMAN OTC DRUG · 20250530

Indications and Usage

openFDA Drug Labeling

Uses 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 skin problems because you are more likely to get rashes. 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 do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch. 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 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 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 used patch 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 One (in each patch) Nicotine, 21 mg delivered over 24 hours

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

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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-1148 NDC: 50090-1148-0 1 h in a POUCH / 14 in a CARTON Product: 50090-1694 NDC: 50090-1694-0 1 h in a POUCH / 14 in a CARTON Product: 50090-1697 NDC: 50090-1697-0 1 h in a POUCH / 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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class III June 3, 2026 AVEVA Drug Delivery Systems, Inc. Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. Ongoing

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
50090-1148-0 50090-1148 A-S Medication Solutions 14 POUCH in 1 CARTON (50090-1148-0) / 1 h in 1 POUCH June 25, 2024
50090-1694-0 50090-1694 A-S Medication Solutions 14 POUCH in 1 CARTON (50090-1694-0) / 1 h in 1 POUCH February 12, 2015
50090-1697-0 50090-1697 A-S Medication Solutions 14 POUCH in 1 CARTON (50090-1697-0) / 1 h in 1 POUCH February 13, 2015
79481-0052-1 79481-0052 Meijer, Inc. 14 POUCH in 1 CARTON (79481-0052-1) / 1 h in 1 POUCH March 20, 2024
79481-0053-1 79481-0053 Meijer, Inc. 14 POUCH in 1 CARTON (79481-0053-1) / 1 h in 1 POUCH March 20, 2024
79481-0054-1 79481-0054 Meijer, Inc. 14 POUCH in 1 CARTON (79481-0054-1) / 1 h in 1 POUCH March 20, 2024
0536-5894-53 0536-5894 Rugby Laboratories 7 POUCH in 1 CARTON (0536-5894-53) / 1 h in 1 POUCH June 25, 2024
0536-5894-88 0536-5894 Rugby Laboratories 14 POUCH in 1 CARTON (0536-5894-88) / 1 h in 1 POUCH June 25, 2024
0536-5895-53 0536-5895 Rugby Laboratories 7 POUCH in 1 CARTON (0536-5895-53) / 1 h in 1 POUCH June 25, 2024
0536-5895-71 0536-5895 Rugby Laboratories 28 POUCH in 1 CARTON (0536-5895-71) / 1 h in 1 POUCH June 25, 2024
0536-5895-88 0536-5895 Rugby Laboratories 14 POUCH in 1 CARTON (0536-5895-88) / 1 h in 1 POUCH June 25, 2024
0536-5896-53 0536-5896 Rugby Laboratories 7 POUCH in 1 CARTON (0536-5896-53) / 1 h in 1 POUCH June 25, 2024
0536-5896-71 0536-5896 Rugby Laboratories 28 POUCH in 1 CARTON (0536-5896-71) / 1 h in 1 POUCH June 25, 2024
0536-5896-88 0536-5896 Rugby Laboratories 14 POUCH in 1 CARTON (0536-5896-88) / 1 h in 1 POUCH June 25, 2024
70677-0032-1 70677-0032 Strategic Sourcing Services LLC 14 POUCH in 1 CARTON (70677-0032-1) / 1 h in 1 POUCH December 4, 2017
50090-1148 50090-1148 A-S Medication Solutions — June 25, 2024
50090-1694 50090-1694 A-S Medication Solutions — October 20, 1997
50090-1697 50090-1697 A-S Medication Solutions — October 20, 1997
79481-0052 79481-0052 Meijer, Inc. — March 20, 2024
79481-0053 79481-0053 Meijer, Inc. — March 20, 2024
79481-0054 79481-0054 Meijer, Inc. — March 20, 2024
0536-5894 0536-5894 Rugby Laboratories — June 25, 2024
0536-5895 0536-5895 Rugby Laboratories — June 25, 2024
0536-5896 0536-5896 Rugby Laboratories — June 25, 2024
70677-0032 70677-0032 Strategic Sourcing Services LLC — December 4, 2017

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
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.