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Medline
nicotine · Medline is a cholinergic nicotinic agonist (over-the-counter) containing nicotine, made by Medline Industries, LP.
- Type
- Over the counter
- Drug class
- Cholinergic Nicotinic Agonist
- Route
- Transdermal
- Manufacturers
- 1
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
- Patch
- Label holder
- Medline Industries, LP
- FDA application
- ANDA074611
- Label updated
- 11/04/2025
Active ingredients
(in each patch) Step 1: Nicotine, 21 mg delivered over 24 hours Step 2: Nicotine, 14 mg delivered over 24 hours Step 3: 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 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: 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. schedule
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 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, or 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 before use
Ask 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
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
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, or 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.
Inactive ingredients
Acrylate adhesive, polyester, silicone adhesive
Questions?
1-877-748-1970
Forms and strengths
From the FDA NDC Directory · 3 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Patch | 7 mg | transdermal | 1 |
| Patch | 14 mg | transdermal | 1 |
| Patch | 21 mg | transdermal | 1 |
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
1 FDA label
- Medline Industries, LPShown hereANDA074611 · Label 11/04/2025 · NDC 53329-191, 53329-193, 53329-192Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing07/15/2026Medline Remedy Specialized Silicone Cream (Hydraguard-D),Manufactured for Medline Industries, LP, Three...BioMed Laboratories, LLC. · Failed Impurities/Degradation Specifications; Formaldehyde levels...
- 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 IIDrugOngoing10/29/2025Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case...Medline Industries, LP · Subpotent Drug
- Class IIIDrugOngoing10/01/2025READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per...Medline Industries, LP · Subpotent drug
- Class IIDrugOngoing09/03/2025Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large...MEDLINE INDUSTRIES, LP - Northfield · 2 products · Subpotent Drug- isopropyl alcohol levels fall below the labeled...
Medline: common questions
- What is Medline used for?
- reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Is Medline a prescription drug?
- No. Medline is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Medline?
- Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
- Who makes Medline?
- Medline Industries, LP lists Medline with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/04/2025 · Label text is shown as published by the manufacturer. Not medical advice