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    NDC 48878-4061-03 OMNI 0.969 mg/g Details

    OMNI 0.969 mg/g

    OMNI is a ORAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by 3M ESPE Dental Products. The primary component is STANNOUS FLUORIDE.

    Product Information

    NDC 48878-4061
    Product ID 48878-4061_5539e66a-f111-4d1d-b4fd-6d0eaab84a84
    Associated GPIs 88402030004010
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name OMNI
    Proprietary Name Suffix n/a
    Non-Proprietary Name stannous fluoride
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route ORAL
    Active Ingredient Strength 0.969
    Active Ingredient Units mg/g
    Substance Name STANNOUS FLUORIDE
    Labeler Name 3M ESPE Dental Products
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part355
    Listing Certified Through 2024-12-31

    Package

    NDC 48878-4061-03 (48878406103)

    NDC Package Code 48878-4061-3
    Billing NDC 48878406103
    Package 1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE
    Marketing Start Date 1998-02-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 0c2a81b1-65b5-432b-8e66-30432a245aba Details

    Revised: 6/2019