Home NDC 85333-001 Nicotine Patches
Product NDC 85333-001
11-digit product format 853330001
Labeler code 85333
Product ID 85333-001_30a977c3-6863-670e-e063-6294a90aeb2f
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Patches
Dosage form LOTION
Route TOPICAL
Labeler Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-19
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 85333-001-01 Nicotine Patches 42 mg in 1 BOX LOTION 42 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85333-001 NICOTINE PATCHES LOTION [ZHEJIANG FTA SHENGZUOZHI BIOTECHNOLOGY CO., LTD] 1 Current NDC, 1 package rows 20250322_30a977c3-6862-670e-e063-6294a90aeb2f.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 65 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GNP Witch Hazel WITCH HAZEL Amerisource Bergen 45ac839d-215d-4c5f-8ae5-5e111d170061 2023-12-14 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant GLYCERIN L'Oreal USA Products Inc 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief OATMEAL COSMETIQUE ACTIVE PRODUCTION e555de17-9b42-4125-a17b-467bc1d179d7 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief OATMEAL L'Oreal USA Products Inc f7b71606-0044-4729-82e8-4514331806a0 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 GLYCERIN Cosmetique Active Production 01c8a0d5-bcd1-4639-be45-530a226401f0 2023-12-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 0bc6812a-5c2a-7bb9-e063-6294a90a36e3 2023-12-05 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 34fae56e-367d-4659-af2d-1c9ddaf1639c 2023-12-05 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE Rejoice International Corp. 0ba98cdf-489e-dc2a-e063-6294a90adb38 2023-12-04 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE China Ningbo Shangge Cosmetics Technology Corp. 0baa8a14-8655-d77c-e063-6294a90ab8aa 2023-12-04 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 86472a3d-7138-4141-8422-ab20c17a46e0 2023-12-04 Warnings Exact identifier application number: M016 SOOTHE Moisturizing Rescue Cream OATMEAL Rodan & Fields 91163267-c2aa-47b3-b290-d1605536d806 2023-12-04 Warnings Exact identifier application number: M016 Manzatin-E Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. cafd084f-8493-4d6e-b256-2d4b4282f866 2023-12-01 Warnings Exact identifier application number: M016 Manzatin Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. 5c1618a4-ca08-4814-a556-74e79db618b9 2023-12-01 Warnings Exact identifier application number: M016 Petrolatum Jelly PETROLATUM NEW PRIDE CORP f6634410-fa1f-7987-e053-2995a90abb06 2023-12-01 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair Balm DIMETHICONE Galderma Laboratories, L.P. 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956 2023-11-30 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair DIMETHICONE Galderma Laboratories, L.P. 27d74e0f-8359-4c59-bf7f-acade7f4545c 2023-11-30 Warnings Exact identifier application number: M016 Sheffield Advanced Scar Gel ADVANCED SCAR GEL Sheffield Pharmaceuticals LLC ab78b946-81ed-442c-a167-26c26c7fe8a1 2023-11-30 Warnings Exact identifier application number: M016 Akin Diaper Rash ZINC OXIDE Southern Sales & Service, Inc. f5515517-7977-48f9-aab6-cf0d2f2a04a0 2023-11-29 Warnings Exact identifier application number: M016 Dr. Sheffield Diaper Rash ZINC OXIDE Sheffield Pharmaceuticals LLC cac77320-b5cf-4edf-9693-ebabfb61390c 2023-11-28 Warnings Exact identifier application number: M016 Sheffield Zinc Oxide ZINC OXIDE Sheffield Pharmaceuticals LLC 60b54c04-4387-4954-951d-165809947310 2023-11-28 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85333-001-01 85333000101 42 mg in 1 BOX (85333-001-01) 42 mg 2025-03-19 No No Current