Search by Drug Name or NDC

    NDC 43498-0315-30 Burkhart Topical Anesthetic 200 mg/g Details

    Burkhart Topical Anesthetic 200 mg/g

    Burkhart Topical Anesthetic is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Burkhart Dental Supply Inc. The primary component is BENZOCAINE.

    Product Information

    NDC 43498-0315
    Product ID 43498-315_d655b0d2-0fc0-de6b-e053-2995a90a43f7
    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 Burkhart Topical Anesthetic
    Proprietary Name Suffix n/a
    Non-Proprietary Name Benzocaine
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route DENTAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/g
    Substance Name BENZOCAINE
    Labeler Name Burkhart Dental Supply Inc
    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 43498-0315-30 (43498031530)

    NDC Package Code 43498-315-30
    Billing NDC 43498031530
    Package 30 g in 1 JAR (43498-315-30)
    Marketing Start Date 2018-06-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 99bce4c6-4593-40a1-b28d-8334a79b9d42 Details

    Revised: 1/2022