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Nicotine Transdermal System
Nicotine · Film, Extended Release
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cholinergic Nicotinic Agonist [EPC] | EPC | All 61 members |
| Nicotine [CS] | CS | All 61 members |
Regulatory status
Source: Drugs@FDANDC Directory| 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUse reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
Purpose
openFDA Drug LabelingPurpose Stop smoking aid
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive 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 FAERSAttributed 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| 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
| 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.