NDC 51013-801

Eptex 4.5%

Benzoyl Peroxide

Eptex 4.5% is a Topical Liquid, Extended Release in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Benzoyl Peroxide.

Product ID51013-801_60147d64-71a1-8609-e053-2a91aa0aa323
NDC51013-801
Product TypeHuman Otc Drug
Proprietary NameEptex 4.5%
Generic NameBenzoyl Peroxide
Dosage FormLiquid, Extended Release
Route of AdministrationTOPICAL
Marketing Start Date2016-10-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333D
Labeler NamePuraCap Pharmaceutical LLC
Substance NameBENZOYL PEROXIDE
Active Ingredient Strength5 mg/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51013-801-71

177 mL in 1 BOTTLE, PUMP (51013-801-71)
Marketing Start Date2016-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-801-71 [51013080171]

Eptex 4.5% LIQUID, EXTENDED RELEASE
Marketing CategoryOTC monograph final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-23
Marketing End Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
BENZOYL PEROXIDE4.5 mg/100mL

OpenFDA Data

SPL SET ID:b0a5b39a-2250-44f5-9d10-c4b8ee716387
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 845945

    • NDC Crossover Matching brand name "Eptex 4.5%" or generic name "Benzoyl Peroxide"

    NDCBrand NameGeneric Name
    51013-801Eptex 4.5%Eptex 4.5%
    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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