Home NDC 85248-012 Flobow QUIT SMOKING Nicotine
Product NDC 85248-012
11-digit product format 852480012
Labeler code 85248
Product ID 85248-012_495b10ce-3d2e-1aa4-e063-6294a90a4f35
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 2026-01-27
Substance NICOTINE; MENTHOL
Active strength 18; .3 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 Flobow QUIT SMOKING Nicotine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 18 g/1001 MENTHOL .3 g/1001
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup L7T10EIP3A 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 85248-012-01 Flobow 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 48 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 85248-012-01 85248001201 21 PATCH in 1 BOX (85248-012-01) 21 patch 2026-01-27 No No Current