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    NDC 68094-0022-62 Dye Free Childrens Diphenhydramine Hydrochloride 12.5 mg/5mL Details

    Dye Free Childrens Diphenhydramine Hydrochloride 12.5 mg/5mL

    Dye Free Childrens Diphenhydramine Hydrochloride is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Precision Dose, Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 68094-0022
    Product ID 68094-022_4d0f881b-19ef-46b4-ae56-fd7d96e90e78
    Associated GPIs 41200030100920
    GCN Sequence Number 016675
    GCN Sequence Number Description diphenhydramine HCl LIQUID 12.5MG/5ML ORAL
    HIC3 Z2P
    HIC3 Description ANTIHISTAMINES - 1ST GENERATION
    GCN 48831
    HICL Sequence Number 004480
    HICL Sequence Number Description DIPHENHYDRAMINE HCL
    Brand/Generic Generic
    Proprietary Name Dye Free Childrens Diphenhydramine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name diphenhydramine hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route ORAL
    Active Ingredient Strength 12.5
    Active Ingredient Units mg/5mL
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name Precision Dose, Inc.
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 68094-0022-62 (68094002262)

    NDC Package Code 68094-022-62
    Billing NDC 68094002262
    Package 3 TRAY in 1 CASE (68094-022-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-022-59)
    Marketing Start Date 2018-12-27
    NDC Exclude Flag N
    Pricing Information N/A