Home NDC 87278-017 Nicotine Stop Smoking AID Step1
Product NDC 87278-017
11-digit product format 872780017
Labeler code 87278
Product ID 87278-017_57a7a614-5f24-258b-e063-6294a90a94b1
Type HUMAN OTC DRUG
Nonproprietary name Nicotine 21 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 21 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 Step1
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 21 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 198030 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 87278-017-01 87278001701 30 PATCH in 1 BOX (87278-017-01) / 1 PATCH in 1 PATCH 30 patch 2026-07-28 No No Current