Home NDC 68343-123 Dermisa Acne Treatment
Product NDC 68343-123
11-digit product format 683430123
Labeler code 68343
Product ID 68343-123_295765fa-6050-0b18-e063-6394a90a8c49
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form CREAM
Route TOPICAL
Labeler Montani Cosmetics Inc
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-02-28
Substance BENZOYL PEROXIDE
Active strength 5 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 Dermisa Acne Treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 5 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 308693 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 68343-123-01 Dermisa Acne Treatment 28 g in 1 TUBE CREAM 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68343-123 DERMISA ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [MONTANI COSMETICS INC] 2 Current NDC, Legacy NDC, 1 package rows 20241217_d61a6354-8194-da19-e053-2995a90a7e22.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 7 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 68343-123-01 68343012301 28 g in 1 TUBE (68343-123-01) 28 g 2013-02-28 0000-00-00 No No Current