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    NDC 42192-0162-15 BPO 4% 4 mg/100mg Details

    BPO 4% 4 mg/100mg

    BPO 4% 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 42192-0162
    Product ID 42192-162_b8543d1e-86f9-6431-e053-2995a90a6c3c
    Associated GPIs 90050010004012
    GCN Sequence Number 015936
    GCN Sequence Number Description benzoyl peroxide GEL (GRAM) 4 % TOPICAL
    HIC3 L5A
    HIC3 Description KERATOLYTICS
    GCN 22935
    HICL Sequence Number 002470
    HICL Sequence Number Description BENZOYL PEROXIDE
    Brand/Generic Generic
    Proprietary Name BPO 4%
    Proprietary Name Suffix n/a
    Non-Proprietary Name Benzoyl Peroxide
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 4
    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 42192-0162-15 (42192016215)

    NDC Package Code 42192-162-15
    Billing NDC 42192016215
    Package 42500 mg in 1 TUBE (42192-162-15)
    Marketing Start Date 2019-01-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL b7cf792a-10a6-4d70-813f-527766dc4d9f Details

    Revised: 1/2021