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    NDC 54859-0503-01 Orasep 2; .1; .5 mg/100mL; mg/100mL; mg/100mL Details

    Orasep 2; .1; .5 mg/100mL; mg/100mL; mg/100mL

    Orasep is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL.

    Product Information

    NDC 54859-0503
    Product ID 54859-503_e68250f2-c90d-4555-8d98-55b5906df24b
    Associated GPIs 88359903242020
    GCN Sequence Number 016328
    GCN Sequence Number Description benzocaine/tan ac/menth/cpyrd SOLUTION MUCOUS MEM
    HIC3 H0A
    HIC3 Description LOCAL ANESTHETICS
    GCN 68050
    HICL Sequence Number 006219
    HICL Sequence Number Description BENZOCAINE/TANNIC ACID/MENTHOL/CETYLPYRIDINIUM CHLORIDE
    Brand/Generic Brand
    Proprietary Name Orasep
    Proprietary Name Suffix n/a
    Non-Proprietary Name Benzocaine, Menthol, Cetylpyridinium Chloride
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route TOPICAL
    Active Ingredient Strength 2; .1; .5
    Active Ingredient Units mg/100mL; mg/100mL; mg/100mL
    Substance Name BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL
    Labeler Name Llorens Pharmaceutical International Division
    Pharmaceutical Class Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part356
    Listing Certified Through 2024-12-31

    Package

    NDC 54859-0503-01 (54859050301)

    NDC Package Code 54859-503-01
    Billing NDC 54859050301
    Package 30 mL in 1 BOTTLE (54859-503-01)
    Marketing Start Date 2010-04-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ed70911b-9da8-4e1d-97fa-66b18d28516a Details

    Revised: 12/2020