NDC 49825-124

Breakout Control Acne Treatment

Benzoyl Peroxide

Breakout Control Acne Treatment is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Bioelements, Inc.. The primary component is Benzoyl Peroxide.

Product ID49825-124_c1266138-fbc3-4663-a73d-6d941851823b
NDC49825-124
Product TypeHuman Otc Drug
Proprietary NameBreakout Control Acne Treatment
Generic NameBenzoyl Peroxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2012-03-26
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333D
Labeler NameBioelements, Inc.
Substance NameBENZOYL PEROXIDE
Active Ingredient Strength5 mL/100mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 49825-124-02

1 JAR in 1 BOX (49825-124-02) > 29 mL in 1 JAR (49825-124-01) (49825-124-01)
Marketing Start Date2012-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49825-124-01 [49825012401]

Breakout Control Acne Treatment LOTION
Marketing CategoryOTC monograph not final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-03-26

NDC 49825-124-02 [49825012402]

Breakout Control Acne Treatment LOTION
Marketing CategoryOTC monograph not final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-03-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BENZOYL PEROXIDE5 mL/100mL

OpenFDA Data

SPL SET ID:58d4eadb-18d2-489e-81f9-5b35bc500367
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 106309

    • NDC Crossover Matching brand name "Breakout Control Acne Treatment" or generic name "Benzoyl Peroxide"

    NDCBrand NameGeneric Name
    49825-124Breakout Control Acne TreatmentBreakout Control Acne Treatment
    0363-0137Acne Cleansing BarBenzoyl Peroxide
    0363-0229Acne TreatmentBenzoyl peroxide
    0187-1613AcneFreebenzoyl peroxide
    0187-1610AcneFree Clear Skin TreatmentsBenzoyl Peroxide
    0187-1611AcneFree Clear Skin Treatmentsbenzoyl peroxide
    0187-5012AcneFree Clear Skin Treatmentsbenzoyl peroxide
    0187-1612AcneFree SensitiveBenzoyl Peroxide
    0187-1616AcneFree Severe Terminatorbenzoyl peroxide
    0187-0194BenzEFoambenzoyl peroxide
    0187-0201BenzEFoam Ultrabenzoyl peroxide
    0299-4125Cetaphil Gentle Clear BPO Acne Cleanserbenzoyl peroxide
    0187-6101CLENZIDERM THERAPEUTICBENZOYL PEROXIDE
    0363-0264Daily Acne Control CleanserBenzoyl peroxide
    0299-4606Differin Daily Deep Cleanser with BPObenzoyl peroxide
    0299-5890EPSOLAYBenzoyl Peroxide
    0179-8702kaiser permanente benzoyl peroxideBENZOYL PEROXIDE
    0179-8703kaiser permanente benzoyl peroxideBENZOYL PEROXIDE
    0179-8704kaiser permanente benzoyl peroxideBENZOYL PEROXIDE
    0179-8705kaiser permanente benzoyl peroxideBENZOYL PEROXIDE
    0145-0983PanOxylbenzoyl peroxide
    0145-0985PanOxylbenzoyl peroxide
    0145-2660PanOxylbenzoyl peroxide
    0316-0227PanOxylbenzoyl peroxide
    0316-0228PanOxylbenzoyl peroxide
    0023-4965SkinMedica Acne Treatmentbenzoyl peroxide
    0363-0467Walgreens Acne Foaming CleanserBenzoyl Peroxide
    0363-1522Walgreens Acne Foaming WashBenzoyl Peroxide
    0363-0116Walgreens Acne Spot TreatmentBenzoyl Peroxide
    0295-0010Zapzyt Acnebenzoyl peroxide
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