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NICOTINE
Overview
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 020076-001 | HABITROL | Film, Extended Release | NICOTINE | Discontinued | — | ||
| 020076-002 | HABITROL | Film, Extended Release | NICOTINE | Discontinued | — | ||
| 020076-003 | HABITROL | Film, Extended Release | NICOTINE | Discontinued | — | ||
| 020076-004 | HABITROL | FILM, EXTENDED RELEASE | NICOTINE | Over-the-counter | — | RLD | |
| 020076-005 | HABITROL | FILM, EXTENDED RELEASE | NICOTINE | Over-the-counter | — | RLD | |
| 020076-006 | HABITROL | FILM, EXTENDED RELEASE | NICOTINE | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 51 | Labeling | Approved | January 2, 2019 | Standard |
| Supplement | 49 | Labeling | Approved | June 27, 2018 | Standard |
| Supplement | 45 | Labeling | Approved | July 23, 2017 | Standard |
| Supplement | 42 | Labeling | Approved | July 6, 2016 | Standard |
| Supplement | 43 | Labeling | Approved | July 5, 2016 | Standard |
| Supplement | 41 | Labeling | Approved | May 10, 2016 | Standard |
| Supplement | 40 | Manufacturing (CMC) | Approved | May 9, 2016 | Standard |
| Supplement | 39 | Manufacturing (CMC) | Approved | April 4, 2016 | Standard |
| Supplement | 38 | Manufacturing (CMC) | Approved | January 19, 2016 | Standard |
| Supplement | 37 | Manufacturing (CMC) | Approved | November 17, 2015 | Standard |
| Supplement | 36 | Labeling | Approved | July 25, 2014 | Standard |
| Supplement | 35 | Manufacturing (CMC) | Approved | May 16, 2013 | Standard |
| Supplement | 29 | Labeling | Approved | May 5, 2006 | Standard |
| Supplement | 28 | Labeling | Approved | November 22, 2005 | Standard |
| Supplement | 27 | Manufacturing (CMC) | Approved | October 21, 2004 | Standard |
| Supplement | 24 | Labeling | Approved | February 6, 2004 | Standard |
| Supplement | 25 | Labeling | Approved | January 21, 2004 | Standard |
| Supplement | 21 | Labeling | Approved | July 15, 2002 | Standard |
| Supplement | 20 | Labeling | Approved | July 12, 2002 | Standard |
| Supplement | 18 | Manufacturing (CMC) | Approved | November 7, 2000 | Standard |
| Supplement | 17 | Manufacturing (CMC) | Approved | January 31, 2000 | Standard |
| Supplement | 15 | Manufacturing (CMC) | Approved | December 3, 1999 | Standard |
| Supplement | 11 | Efficacy | Approved | November 12, 1999 | Standard |
| Supplement | 13 | Efficacy | Approved | January 7, 1999 | Standard |
| Supplement | 14 | Manufacturing (CMC) | Approved | October 29, 1998 | Standard |
| Supplement | 9 | Manufacturing (CMC) | Approved | July 24, 1996 | Standard |
| Supplement | 7 | Manufacturing (CMC) | Approved | February 8, 1996 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | October 6, 1995 | Standard |
| Supplement | 6 | Manufacturing (CMC) | Approved | October 6, 1994 | Standard |
| Supplement | 4 | Manufacturing (CMC) | Approved | July 21, 1992 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | July 21, 1992 | Standard |
| Supplement | 1 | Manufacturing (CMC) | Approved | January 6, 1992 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | November 27, 1991 | Standard |
Review documents
- 0 · Supplement · February 1, 2019
- 0 · Supplement · January 4, 2019
- 0 · Supplement · July 6, 2018
- 0 · Supplement · July 6, 2018
- 0 · Supplement · July 26, 2017
- 0 · Supplement · July 25, 2017
- 0 · Supplement · July 18, 2016
- 0 · Supplement · July 8, 2016
- 0 · Supplement · July 7, 2016
- 0 · Supplement · July 7, 2016
- 0 · Supplement · June 17, 2016
- 0 · Supplement · May 16, 2016
- 0 · Supplement · July 29, 2014
- 0 · Supplement · July 28, 2014
- 0 · Supplement · May 16, 2006
- 0 · Supplement · November 30, 2005
- 0 · Supplement · October 29, 2004
- 0 · Supplement · March 3, 2004
- 0 · Supplement · January 22, 2004
- 0 · Supplement · July 15, 2002
- 0 · Supplement · July 15, 2002
- 0 · Supplement · July 12, 2002
- 0 · Supplement · July 12, 2002
- 0 · Supplement · November 12, 1999
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240725). 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 • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1 STEP 2 STEP 3 Use one 21mg patch/day Use one 14mg patch/day Use one 7mg patch/day Weeks 1-4 Weeks 5-6 Weeks 7-8 • if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop • 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 • stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.
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. Do not use • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products 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. 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 blood stream 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 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 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.
Do Not Use
openFDA Drug LabelingDo not use • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products
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.
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
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
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 55741-449-56 | 55741-449 | Dr. Reddy's Laboratories Inc. | 56 PATCH in 1 CARTON (55741-449-56) / 1 KIT in 1 PATCH | May 14, 2015 |
| 43598-445-56 | 43598-445 | Dr. Reddys Laboratories Inc. | 56 PATCH in 1 CARTON (43598-445-56) / 1 KIT in 1 PATCH | May 14, 2015 |
| 11822-3627-3 | 11822-3627 | Rite Aid Corporation | 56 PATCH in 1 CARTON (11822-3627-3) / 1 KIT in 1 PATCH | March 31, 2021 |
| 55741-449 | 55741-449 | Dr. Reddy's Laboratories Inc. | — | May 14, 2015 |
| 43598-445 | 43598-445 | Dr. Reddys Laboratories Inc. | — | May 14, 2015 |
| 11822-3627 | 11822-3627 | Rite Aid Corporation | — | March 31, 2021 |
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 |
Generated September 25, 2026 · 9 sections on this page.