Home NDC 83804-001-01 SEFUDUN QUIT SMOKING NICOTINE PATCHES
Product NDC 83804-001
Requested package NDC 83804-001-01
11-digit product format 838040001
Labeler code 83804
Product ID 83804-001_314e6f25-8fd1-38ba-e063-6294a90aca8b
Type HUMAN OTC DRUG
Nonproprietary name nicotine
Dosage form PATCH
Route TRANSDERMAL
Labeler Shenzhen Shandian Jingling Technology Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-27
Substance NICOTINE
Active strength 21 mg/1
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 SEFUDUN QUIT SMOKING NICOTINE PATCHES
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 21 mg/1
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 83804-001-01 SEFUDUN QUIT SMOKING NICOTINE PATCHES 30 in 1 BOX PATCH 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83804-001 SEFUDUN QUIT SMOKING NICOTINE PATCHES (NICOTINE) PATCH [SHENZHEN SHANDIAN JINGLING TECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20250330_314e6f25-8fd0-38ba-e063-6294a90aca8b.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 1 of 1 · 1 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 83804-001-01 83804000101 30 PATCH in 1 BOX (83804-001-01) 30 patch 2025-03-27 No No Current