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Nicotine Transdermal System
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 20260318). 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 • 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
openFDA Drug LabelingWARNINGS 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 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 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 LabelingHOW SUPPLIED Product: 50090-7936 NDC: 50090-7936-0 24 h in a PATCH / 14 in a CARTON
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 |
|---|---|---|---|---|
| 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
| 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.