NDC 42485-003

OC Eight

Benzoyl Peroxide

OC Eight is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Biopelle, Inc.. The primary component is Benzoyl Peroxide.

Product ID42485-003_d95c940a-8f82-4928-8512-188b9f9224f0
NDC42485-003
Product TypeHuman Otc Drug
Proprietary NameOC Eight
Generic NameBenzoyl Peroxide
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2011-04-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333D
Labeler NameBiopelle, Inc.
Substance NameBENZOYL PEROXIDE
Active Ingredient Strength7 mg/g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 42485-003-01

45 g in 1 TUBE (42485-003-01)
Marketing Start Date2011-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42485-003-01 [42485000301]

OC Eight GEL
Marketing CategoryOTC monograph not final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-01
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
BENZOYL PEROXIDE7 mg/g

OpenFDA Data

SPL SET ID:018288db-8278-4e5d-8749-4745c64663a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 259256
  • 1116916
  • NDC Crossover Matching brand name "OC Eight" or generic name "Benzoyl Peroxide"

    NDCBrand NameGeneric Name
    42485-003OC EightOC Eight
    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

    Trademark Results [OC Eight]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OC EIGHT
    OC EIGHT
    78487812 3633103 Live/Registered
    FERNDALE IP, INC.
    2004-09-22

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