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 3 of 23 · 456 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: ZY81Z83H0X
unii: 059QF0KO0R
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
unii: ZY81Z83H0X
clindamycin and benzoyl peroxideCLINDAMYCIN AND BENZOYL PEROXIDENorthStar RxLLCe19de12c-f29b-42ab-9e81-1af8e4a666432026-06-04Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Acne Control SerumBENZOYL PEROXIDEPrivate Label Skin Cared4a4b89f-c9cf-4188-9c61-e8ef22b7638c2026-06-03WarningsExact identifier
rxcui: 106309
unii: W9WZN9A0GM
BellamiLuxx Body acne cleanserBENZOYL PEROXIDE 4%BellamiLuxx LLC532baae0-7e6f-1764-e063-6394a90a11ce2026-06-01WarningsExact identifier
unii: W9WZN9A0GM
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPOBENZOYL PEROXIDELOreal USA Products Inc851882ac-56f4-4bf6-b942-6efea10eec3e2026-05-26WarningsExact identifier
unii: W9WZN9A0GM
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Differin EpiduoADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.ae3f8cd9-9046-4b69-b80f-3e9d4468ba7f2026-05-20WarningsExact identifier
unii: W9WZN9A0GM
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Clearasil Rapid Rescue Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCcae9204d-4b6f-4fc7-9857-3050ffd6d2fa2026-05-13WarningsExact identifier
unii: W9WZN9A0GM
Clearasil Stubborn Acne Control 5in1 Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCbdb87e60-67a6-4c0e-b0ab-3e238a08269c2026-05-13WarningsExact identifier
unii: W9WZN9A0GM
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
unii: ZY81Z83H0X
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 1VPU26JZZ4
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
unii: ZY81Z83H0X
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
unii: ZY81Z83H0X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Zapzyt Acne Treatment GelBENZOYL PEROXIDEFocus Consumer Healthcare, LLC6079d45c-dd86-6f2e-e053-2991aa0a97432026-04-29WarningsExact identifier
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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