Home NDC 78518-295 Monat Acne Treatment
Product NDC 78518-295
11-digit product format 785180295
Labeler code 78518
Product ID 78518-295_29b74e5c-3ee4-9bc6-e063-6394a90a50f1
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form CREAM
Route TOPICAL
Labeler Monat Global Corp
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-21
Substance BENZOYL PEROXIDE
Active strength 5 g/100mL
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 Monat Acne Treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 5 g/100mL
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 78518-295-01 Monat Acne Treatment 15 mL in 1 TUBE CREAM 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78518-295 MONAT ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [MONAT GLOBAL CORP] 2 Current NDC, 1 package rows 20241222_f76eb53e-643d-52cf-e053-6394a90a6e8f.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 Sample Exclude flag Status 78518-295-01 78518029501 15 mL in 1 TUBE (78518-295-01) 15 ml 2023-03-21 No No Current