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    NDC 54859-0504-01 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 54859-0504
    Product ID 54859-504_4176f4cc-cc29-4715-90fc-3c6d739f339d
    Associated GPIs 88359903242020
    GCN Sequence Number 070895
    GCN Sequence Number Description benzocaine/menth/cetylpyrd Cl SPRAY 2-0.5-0.1% MUCOUS MEM
    HIC3 H0A
    HIC3 Description LOCAL ANESTHETICS
    GCN 34559
    HICL Sequence Number 011964
    HICL Sequence Number Description BENZOCAINE/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 54859-0504-01 (54859050401)

    NDC Package Code 54859-504-01
    Billing NDC 54859050401
    Package 30 mL in 1 BOTTLE, SPRAY (54859-504-01)
    Marketing Start Date 2010-04-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 7c50d986-6a7b-425f-90a0-a60e21283bdf Details

    Revised: 12/2020