Home NDC 85333-002 Nicotine Patches
Product NDC 85333-002
11-digit product format 853330002
Labeler code 85333
Product ID 85333-002_313b0492-51e6-bf6d-e063-6394a90a3a05
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 2025-03-18
Substance NICOTINE
Active strength 42 mg/42mg
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 42 mg/42mg
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 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 85333-002-01 Nicotine Patches 42 mg in 1 PATCH PATCH 42 1 85333-002-02 Nicotine Patches 14 in 1 BOX PATCH 14 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85333-002 NICOTINE PATCHES PATCH [ZHEJIANG FTA SHENGZUOZHI BIOTECHNOLOGY CO., LTD] 1 Current NDC, 2 package rows 20250327_313b08e2-d764-96da-e063-6294a90ab705.zip
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 28 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85333-002-01 85333000201 42 mg in 1 PATCH 42 mg Historical 85333-002-02 85333000202 14 PATCH in 1 BOX (85333-002-02) / 42 mg in 1 PATCH (85333-002-01) 14 patch 2025-03-18 No No Current