Home NDC 56152-4009 Breakout Control
Product NDC 56152-4009
11-digit product format 561524009
Labeler code 56152
Product ID 56152-4009_40d3a1b2-45e6-3f6f-e063-6294a90a2ac2
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form CREAM
Route TOPICAL
Labeler Cosmetic Enterprises Ltd
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-06-14
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 Breakout Control
Brand name suffix Bioelements
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 56152-4009-1 Breakout ControlBioelements 29 mL in 1 BOTTLE CREAM 29 5 56152-4009-2 Breakout ControlBioelements 1 in 1 CARTON CREAM 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZOYL PEROXIDE ACTIVE INGREDIENT W9WZN9A0GM BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 BENZOYL PEROXIDE ACTIVE MOIETY W9WZN9A0GM BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) INACTIVE INGREDIENT 86FQE96TZ4 BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 PENTYLENE GLYCOL INACTIVE INGREDIENT 50C1307PZG BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 PHYTIC ACID INACTIVE INGREDIENT 7IGF0S7R8I BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 SQUALANE INACTIVE INGREDIENT GW89575KF9 BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56152-4009 BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [COSMETIC ENTERPRISES LTD] 4 Current NDC, Legacy NDC, 2 package rows 20241105_94462332-2169-4ea1-86b3-25ab9646c6e5.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 56152-4009-1 56152400901 29 mL in 1 BOTTLE 29 ml Historical 56152-4009-2 56152400902 1 BOTTLE in 1 CARTON (56152-4009-2) / 29 mL in 1 BOTTLE (56152-4009-1) 1 bottle 2013-06-14 0000-00-00 No No Current