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Nicotine transdermal system
nicotine · Nicotine transdermal system is a cholinergic nicotinic agonist (over-the-counter) containing nicotine, made by 6 manufacturers.
- Type
- Over the counter
- Drug class
- Cholinergic Nicotinic Agonist
- Route
- Transdermal
- Manufacturers
- 6
- + 1 repackager labels
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Drug facts
- Generic name
- nicotine
- Active ingredients
- Nicotine
- Drug class
- Cholinergic Nicotinic Agonist
- Dosage forms
- Film, extended release, Kit, Patch, extended release
- Label holder
- Wal-Mart Stores Inc
- FDA application
- NDA020165
- Label updated
- 03/13/2026
Active ingredients
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
Purpose
Stop smoking aid
Uses
Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Directions
- If you are under 18 years of age, ask a doctor before use
- Before using this product, read the enclosed User’s 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 according to the following 10 week schedule: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10
- If you smoke 10 or less cigarettes per day, do not use STEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks, then STEP 3 (7 mg) for 2 weeks and then stop.
- Steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
- Apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
- Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
- Wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.
- You may wear the patch for 16 or 24 hours.
- If you crave cigarettes when you wake up, wear the patch for 24 hours.
- If you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
- The used patch should be removed and a new one applied to a different skin site at the same time each day
- 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 healthcare 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 have skin problems because you are more likely to get rashes
- Stomach ulcers 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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
Ask a doctor before use
- 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 ulcers or diabetes
- History of seizures
Ask a doctor or pharmacist before use
- 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
- 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)
Pregnancy or breastfeeding
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.
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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
Inactive ingredients
Ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings
Questions?
Call 1-888-287-1915
Forms and strengths
From the FDA NDC Directory · 13 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Film, extended release | 7 mg/24h | transdermal | 1 |
| Film, extended release | 14 mg/24h | transdermal | 1 |
| Film, extended release | 21 mg/24h | transdermal | 1 |
| Kit | - | transdermal | 2 |
| Patch, extended release | 7 mg/24h | transdermal | 2 |
| Patch, extended release | 14 mg/24h | transdermal | 2 |
| Patch, extended release | 21 mg/24h | transdermal | 4 |
What pharmacies pay
National Average Drug Acquisition Cost (NADAC), week of 10/21/2026
Pharmacies paid about $1.32 to $1.99 per tablet, capsule or unit across 4 package codes.
NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 40,213 reports that list nicotine, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective5,266
- Nausea3,270
- Application site erythema3,142
- Application site pruritus3,069
- Nicotine dependence2,751
- Dizziness1,910
- Headache1,645
- Malaise1,636
- Wrong technique in product usage process1,257
- Vomiting1,255
To report a side effect, use FDA MedWatch.
Manufacturers and labels
7 FDA labels · 1 from repackagers
- Wal-Mart Stores IncShown hereNDA020165 · Label 01/26/2026 · NDC 49035-194, 49035-195, 49035-196Full label
- Dr. Reddy's Laboratories Inc.NDA020076 · Label 07/25/2024 · NDC 55741-449Full label
- Dr. Reddys Laboratories Inc.NDA020076 · Label 07/25/2024 · NDC 43598-445Full label
- EXELAN PHARMACEUTICALS, INC.ANDA074612 · Label 06/01/2025 · NDC 76282-782, 76282-783, 76282-781Full label
- Sam's West IncNDA020165 · Label 06/10/2025 · NDC 68196-194Full label
- Target CorporationNDA020165 · Label 06/10/2025 · NDC 11673-194, 11673-195, 11673-196Full label
Repackager labels (1)
- A-S Medication Solutions03/13/2026
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrugOngoing06/03/2026Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES...AVEVA Drug Delivery Systems, Inc. · Failed Impurities/Degradation Specifications: Elevated levels of...
- Class IIIDrug10/07/2020Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By...P & L Developments, LLC · Labeling: Incorrect or Missing Package Insert: The package insert...
- Class IIIDrug09/03/2014Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave...Perrigo Holland Inc · Failed Dissolution Specifications and Failed Tablet...
- Class IIIDrug04/30/2014Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials....GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline · 10 products · Failed Lozenge Specifications; Lozenges are overly thick, overly...
- Class IIDrug01/29/2014NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.Aidapak Services, LLC · 2 products · Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have...
Nicotine transdermal system: common questions
- What is Nicotine transdermal system used for?
- reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Is Nicotine transdermal system a prescription drug?
- No. Nicotine transdermal system is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Nicotine transdermal system?
- Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
- Who makes Nicotine transdermal system?
- 6 manufacturers list Nicotine transdermal system with the FDA, including Wal-Mart Stores Inc, Dr. Reddy's Laboratories Inc., Dr. Reddys Laboratories Inc.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/13/2026 · Label text is shown as published by the manufacturer. Not medical advice