NDC 49825-129

Breakout Control Bioelements

Benzoyl Peroxide

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

Product ID49825-129_b871db28-caa1-48da-9906-94f0dc223d05
NDC49825-129
Product TypeHuman Otc Drug
Proprietary NameBreakout Control Bioelements
Generic NameBenzoyl Peroxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-06-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333D
Labeler NameBioelements, Inc.
Substance NameBENZOYL PEROXIDE
Active Ingredient Strength5 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49825-129-02

1 BOTTLE in 1 CARTON (49825-129-02) > 29 mL in 1 BOTTLE (49825-129-01)
Marketing Start Date2013-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49825-129-01 [49825012901]

Breakout Control Bioelements CREAM
Marketing CategoryOTC monograph final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-14

NDC 49825-129-02 [49825012902]

Breakout Control Bioelements CREAM
Marketing CategoryOTC monograph final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-14

Drug Details

Active Ingredients

IngredientStrength
BENZOYL PEROXIDE5 g/100mL

OpenFDA Data

SPL SET ID:3546feee-7568-4b58-bb32-3dfcda7da694
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308693
    • UPC Code
  • 0836490001919

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

    NDCBrand NameGeneric Name
    49825-129Breakout Control BioelementsBreakout Control Bioelements
    56152-4009Breakout Control BioelementsBreakout Control Bioelements
    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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