Home NDC 45802-308 benzoyl peroxide
Product NDC 45802-308
11-digit product format 458020308
Labeler code 45802
Product ID 45802-308_560798ff-c57f-4c10-82d8-f69fb0d7839f
Type HUMAN OTC DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form GEL
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-04-06
Substance BENZOYL PEROXIDE
Active strength 10 g/100g
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 benzoyl peroxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 486131 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 45802-308-01 benzoyl peroxide 1 in 1 CARTON GEL 1 5 45802-308-01 benzoyl peroxide 90 g in 1 TUBE GEL 90 5 45802-308-96 benzoyl peroxide 60 g in 1 TUBE GEL 60 5 45802-308-96 benzoyl peroxide 1 in 1 CARTON GEL 1 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-308 BENZOYL PEROXIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] 5 Current NDC, Legacy NDC, 4 package rows 20241025_9702add4-ea36-4c6b-9402-87b44f989a80.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 17 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45802-308-01 45802030801 1 TUBE in 1 CARTON (45802-308-01) / 90 g in 1 TUBE 1 tube 2012-04-13 0000-00-00 No No Current 45802-308-96 45802030896 1 TUBE in 1 CARTON (45802-308-96) / 60 g in 1 TUBE 1 tube 2016-04-06 0000-00-00 No No Current