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    NDC 58809-0116-08 TexaClear Nighttime Sleep-Aid 50 mg/30mL Details

    TexaClear Nighttime Sleep-Aid 50 mg/30mL

    TexaClear Nighttime Sleep-Aid is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GM Pharmaceuticals, Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 58809-0116
    Product ID 58809-116_0370aa49-e4ba-004c-e063-6294a90ab667
    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 TexaClear Nighttime Sleep-Aid
    Proprietary Name Suffix n/a
    Non-Proprietary Name Diphenhydramine HCl
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/30mL
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name GM Pharmaceuticals, 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 58809-0116-08 (58809011608)

    NDC Package Code 58809-116-08
    Billing NDC 58809011608
    Package 237 mL in 1 BOTTLE (58809-116-08)
    Marketing Start Date 2016-06-15
    NDC Exclude Flag N
    Pricing Information N/A