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 14 of 23 · 454 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE INTERVENTION DUALITY MDBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.6d885fe2-8a2d-44d4-84d9-932c48260f792024-11-15WarningsExact identifier
unii: W9WZN9A0GM
AGE INTERVENTION DUALITYBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.33fb5893-ea63-49a3-bb02-6b98c747c4fe2024-11-15WarningsExact identifier
unii: W9WZN9A0GM
Meijer Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEMeijer Distribution, Inccbf0587a-29c4-47ce-bd09-2bccaddba3b72024-11-15WarningsExact identifier
unii: W9WZN9A0GM
amazon basics acne foaming cleanser Acne TreatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLCbdfbaeab-137a-49d5-bdc3-06349b8a05642024-11-14WarningsExact identifier
unii: W9WZN9A0GM
CVS Health Acne Control Cleanser Acne MedicationBENZOYL PEROXIDECVS Health7222a5d0-29d6-43a9-916a-86af662c4f562024-11-12WarningsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBryant Ranch Prepackdb39492e-d964-4e59-8d65-0a2194e9a3d42024-11-11Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDENorthstar Rx LLC2fcf4e8d-dd05-49c2-948b-10abbb52e4bc2024-11-08Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEBryant Ranch Prepackc2b4c7a4-05e5-4e94-9f09-7f8f68f99eab2024-11-07Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutions98e1bf69-ef71-4e38-8357-54c60d9d03df2024-11-06WarningsExact identifier
unii: W9WZN9A0GM
Clean and Clear Persa-Gel 10BENZOYL PEROXIDEKenvue Brands LLCec5d1347-bee9-4dbd-9778-ff7519b600412024-11-06WarningsExact identifier
unii: W9WZN9A0GM
Avene Cleanance Acne Medicated Clearing TreatmentBENZOYL PEROXIDEPierre Fabre USA Inc.facb99a0-f67e-80bf-e053-6294a90a23322024-11-06WarningsExact identifier
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
unii: W9WZN9A0GM
Meijer Acne Treatment Acne medicationBENZOYL PEROXIDEMeijer Distribution, Incf008ad20-03d0-45ae-8f75-249310eb9e702024-11-06WarningsExact identifier
unii: W9WZN9A0GM
Meijer Invisible Acne Acne medicationBENZOYL PEROXIDEMeijer Distribution, Inc2a6ec3dd-572d-4314-afbf-23aff0d1e22a2024-11-06WarningsExact identifier
unii: W9WZN9A0GM
Vivant BP10% Gel MedicationBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10cc63b8-b4f9-6a78-e063-6294a90aade42024-11-05WarningsExact identifier
unii: W9WZN9A0GM
Vivant BP3% Exfoliating CleanserBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10be3c7d-d09c-53a7-e063-6294a90a4f092024-11-05WarningsExact identifier
unii: W9WZN9A0GM
Vivant BP3% Acne WashBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10bf5723-225f-67d7-e063-6394a90a72b12024-11-05WarningsExact identifier
unii: W9WZN9A0GM
Walgreens Acne Control Cleanser Acne MedicationBENZOYL PEROXIDEWalgreen Companyf33e4204-fed9-4f14-a00f-c81b1910254b2024-10-31WarningsExact identifier
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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