Home NDC 0536-1056 Rugby Benzoyl Peroxide
Product NDC 0536-1056
11-digit product format 005361056
Labeler code 0536
Product ID 0536-1056_8e799b87-caf9-4e6d-ad90-835f0345e0ef
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler Rugby Laboratories
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-01-20
Substance BENZOYL PEROXIDE
Active strength 100 mg/mL
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 Rugby Benzoyl Peroxide
Brand name suffix Acne Medication
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 100 mg/mL
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 0536-1056-25 Rugby Benzoyl PeroxideAcne Medication 1 in 1 CARTON GEL 1 11 0536-1056-25 Rugby Benzoyl PeroxideAcne Medication 60 mL in 1 TUBE GEL 60 11 0536-1056-56 Rugby Benzoyl PeroxideAcne Medication 1 in 1 CARTON GEL 1 11 0536-1056-56 Rugby Benzoyl PeroxideAcne Medication 42.5 mL in 1 TUBE GEL 42.5 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Benzoyl Peroxide ACTIVE INGREDIENT W9WZN9A0GM RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Benzoyl Peroxide ACTIVE MOIETY W9WZN9A0GM RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Carboxymethylcellulose Sodium INACTIVE INGREDIENT K679OBS311 RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Laureth-4 INACTIVE INGREDIENT 6HQ855798J RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1056 RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20240210_5cf3da87-ed50-4791-8f71-1b572f3b8f43.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 0536-1056-25 00536105625 1 TUBE in 1 CARTON (0536-1056-25) > 60 mL in 1 TUBE 1 tube 2019-10-15 0000-00-00 No No Current 0536-1056-56 00536105656 1 TUBE in 1 CARTON (0536-1056-56) / 42.5 mL in 1 TUBE 1 tube 2015-01-20 0000-00-00 No No Current