Home NDC 85248-189 BOTASUN QUIT SMOKING Nicotine
Product NDC 85248-189
11-digit product format 852480189
Labeler code 85248
Product ID 85248-189_5442a41b-0157-1562-e063-6394a90a48f3
Type HUMAN OTC DRUG
Nonproprietary name Nicotine18% menthol 0.3% QUIT SMOKING Nicotine
Dosage form PATCH
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-17
Substance MENTHOL; NICOTINE
Active strength .3; 18 g/1001; g/1001
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 BOTASUN QUIT SMOKING Nicotine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .3 g/1001 NICOTINE 18 g/1001
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 6M3C89ZY6R Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85248-189-01 BOTASUN QUIT SMOKING Nicotine 21 in 1 BOX PATCH 21 1
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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85248-189-01 85248018901 21 PATCH in 1 BOX (85248-189-01) 21 patch 2026-04-17 No No Current