Nicotine

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Nicotine
Generic name
NICOTINE
Manufacturer
Strategic Sourcing Services LLC
Product type
HUMAN OTC DRUG
SPL set ID
a08022ff-e412-47f9-8132-318f55528c5c
SPL ID
3b272bb9-e522-8dfa-e063-6294a90a18cc
Version
10
Effective date
2025-07-30
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:37:27
Harmonized routes table
Harmonized routes
TRANSDERMAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 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 bloodstream 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 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 used patch by folding sticky ends together and putting in pouch.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.