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    NDC 54723-0997-01 Comfortox Tetracaine 20 mg/1000mg Details

    Comfortox Tetracaine 20 mg/1000mg

    Comfortox Tetracaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Sambria Pharmaceuticals, Inc.. The primary component is TETRACAINE HYDROCHLORIDE.

    Product Information

    NDC 54723-0997
    Product ID 54723-997_094099ac-1a05-7d6b-e063-6394a90a936b
    Associated GPIs
    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 Comfortox Tetracaine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Tetracaine HCL
    Product Type HUMAN OTC DRUG
    Dosage Form CREAM
    Route TOPICAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/1000mg
    Substance Name TETRACAINE HYDROCHLORIDE
    Labeler Name Sambria Pharmaceuticals, Inc.
    Pharmaceutical Class Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH DRUG
    Application Number M017
    Listing Certified Through 2024-12-31

    Package

    NDC 54723-0997-01 (54723099701)

    NDC Package Code 54723-997-01
    Billing NDC 54723099701
    Package 1500 mg in 1 PACKET (54723-997-01)
    Marketing Start Date 2016-09-14
    NDC Exclude Flag N
    Pricing Information N/A