FDA.reportPublic FDA data

NDC 49825-124-01 - Breakout Control Acne Treatment

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49825-124
Requested NDC
49825-124-01
Package NDCs from labels
49825-124-01, 49825-124-02
Manufacturer
Bioelements, Inc. | Cosmetic Enterprises Ltd
Effective date
2012-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Breakout Control Acne Treatment - Bioelements, Inc. | Cosmetic Enterprises LtdBioelements, Inc. | Cosmetic Enterprises Ltd2012-03-27HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-124-022020-01-31C16284748780-19d75b9d0-3f0a-f424-e053-dadaa90a57ceBreakout Control Acne treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-124-01Breakout ControlAcne Treatment29 mL in 1 JARLOTION291
49825-124-02Breakout ControlAcne Treatment1 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-124BREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1Legacy NDC, 2 package rows20120328_58d4eadb-18d2-489e-81f9-5b35bc500367.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
FYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8IBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
SQUALENEINACTIVE INGREDIENT7QWM220FJHBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBREAKOUT CONTROL ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [BIOELEMENTS, INC.]1

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 10 of 23 · 454 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Erythromycin and Benzoyl PeroxideERYTHROMYCIN AND BENZOYL PEROXIDERising Pharma Holdings, Inc.d449d7e2-5c25-406d-87ab-30809d2924762025-09-05Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEEncube Ethicals, Inc.8ca01174-431e-449a-a85e-8c68d506776c2025-08-29Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticals1d53ec2b-d33d-4245-99f1-e41b303036602025-08-15Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
TwyneoBENZOYL PEROXIDE AND TRETINOINMayne Pharma Commercial LLC654ae869-5bc0-40b3-a423-dcc3270c05d82025-08-11Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
EpsolayBENZOYL PEROXIDEMayne Pharma Commercial LLC641981e6-460b-44dd-8146-306c47e5367c2025-08-11Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
ONEXTONCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC697e760a-c206-4565-8f4e-a8085e2158272025-07-23Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
unii: W9WZN9A0GM
Neutrogena Clear Pore Cleanser MaskBENZOYL PEROXIDEKenvue Brands LLCd020adb5-7f87-42c0-939d-99eb8744f65e2025-07-07WarningsExact identifier
unii: W9WZN9A0GM
ADAPALENE and BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.a53f1aa5-d3d1-45af-8728-8f36090f49da2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.b39aaacb-f429-4cb4-b88b-341b8b8b217c2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.0a98fc1e-be75-4c22-a7a7-2e4f033b37012025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.449884c1-cf3b-4e2c-b8a0-82442ea8523a2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Adapalene and Benzoyl PeroxideADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.13fc72e9-7178-4a8b-9fe8-d88ba591dac82025-07-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEZydus Lifesciences Limitedd374a9b9-3ee9-4bc4-bcb9-a947d76cb6e52025-06-13Exact identifier
unii: W9WZN9A0GM
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEViona Pharmaceuticals Inc3a0fa489-4720-4760-a476-2317aef5a2312025-06-13Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.