Home NDC 85333-003 Nicotine Patches
Product NDC 85333-003
11-digit product format 853330003
Labeler code 85333
Product ID 85333-003_4c1d00b3-313c-933f-e063-6294a90ac46f
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Patches
Dosage form PATCH
Route TRANSDERMAL
Labeler Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-03
Substance NICOTINE
Active strength 21 mg/21mg
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 Patches
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 21 mg/21mg
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85333-003-02 Nicotine Patches 21 mg in 1 PATCH PATCH 21 1 85333-003-02 Nicotine Patches 14 in 1 BOX PATCH 14 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 66 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85333-003-02 85333000302 14 PATCH in 1 BOX (85333-003-02) / 21 mg in 1 PATCH 14 patch 2026-03-03 No No Current