Home NDC 51326-411 Replenix Acne
Product NDC 51326-411
11-digit product format 513260411
Labeler code 51326
Product ID 51326-411_3f4c6873-4988-477e-b77e-0d4d981eb76d
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler Topiderm, Inc
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 1993-01-22
Substance BENZOYL PEROXIDE
Active strength 50 mg/g
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 Replenix Acne
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 50 mg/g
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 308694 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51326-411-57 Replenix Acne 57 g in 1 TUBE GEL 57 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51326-411 REPLENIX ACNE (BENZOYL PEROXIDE) GEL [TOPIDERM, INC] 3 Current NDC, Legacy NDC, 1 package rows 20231108_03d4c298-8f44-41f7-b086-96ae836152bb.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 48 of 54 · 1,079 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 51326-411-57 51326041157 57 g in 1 TUBE (51326-411-57) 57 g 1993-01-22 0000-00-00 No No Current