Home NDC 87278-019 Nicotine Stop Smoking AID Step3
Product NDC 87278-019
11-digit product format 872780019
Labeler code 87278
Product ID 87278-019_57a8b8de-2e22-b5ef-e063-6394a90a6d6a
Type HUMAN OTC DRUG
Nonproprietary name Nicotine 7 mg
Dosage form PATCH
Route TRANSDERMAL
Labeler Guangxi Keyun E-commerce Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-28
Substance NICOTINE
Active strength 7 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nicotine Stop Smoking AID Step3
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 7 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198031 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87278-019-01 87278001901 30 PATCH in 1 BOX (87278-019-01) / 1 PATCH in 1 PATCH 30 patch 2026-07-28 No No Current