Search by Drug Name or NDC

    NDC 69339-0151-17 Diphenhydramine HCl Oral Solution 12.5 mg/5mL Details

    Diphenhydramine HCl Oral Solution 12.5 mg/5mL

    Diphenhydramine HCl Oral Solution is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Natco Pharma USA LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 69339-0151
    Product ID 69339-151_6c998d25-3573-4c6b-822a-1c16eeddd642
    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 Diphenhydramine HCl Oral Solution
    Proprietary Name Suffix n/a
    Non-Proprietary Name diphenhydramine hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 12.5
    Active Ingredient Units mg/5mL
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name Natco Pharma USA LLC
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH DRUG
    Application Number M012
    Listing Certified Through 2024-12-31

    Package

    NDC 69339-0151-17 (69339015117)

    NDC Package Code 69339-151-17
    Billing NDC 69339015117
    Package 4 TRAY in 1 CASE (69339-151-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)
    Marketing Start Date 2020-12-14
    NDC Exclude Flag N
    Pricing Information N/A