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    NDC 42192-0163-15 BPO 8% 8 mg/100mg Details

    BPO 8% 8 mg/100mg

    BPO 8% is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Acella Pharmaceuticals LLC. The primary component is BENZOYL PEROXIDE.

    Product Information

    NDC 42192-0163
    Product ID 42192-163_b8545e47-bdc7-37a5-e053-2995a90a0b87
    Associated GPIs 90050010004014
    GCN Sequence Number 021967
    GCN Sequence Number Description benzoyl peroxide GEL (GRAM) 8 % TOPICAL
    HIC3 L5A
    HIC3 Description KERATOLYTICS
    GCN 22936
    HICL Sequence Number 002470
    HICL Sequence Number Description BENZOYL PEROXIDE
    Brand/Generic Generic
    Proprietary Name BPO 8%
    Proprietary Name Suffix n/a
    Non-Proprietary Name Benzoyl Peroxide
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 8
    Active Ingredient Units mg/100mg
    Substance Name BENZOYL PEROXIDE
    Labeler Name Acella Pharmaceuticals LLC
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part333D
    Listing Certified Through 2022-12-31

    Package

    NDC 42192-0163-15 (42192016315)

    NDC Package Code 42192-163-15
    Billing NDC 42192016315
    Package 42500 mg in 1 TUBE (42192-163-15)
    Marketing Start Date 2019-01-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 38df9a82-d8a7-4d04-b3f3-6c854ac78631 Details

    Revised: 1/2021