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    NDC 50486-0616-32 Sleepinal 50 mg/1 Details

    Sleepinal 50 mg/1

    Sleepinal is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Blairex Laboratories, Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 50486-0616
    Product ID 50486-616_d17a5ee8-52bc-3d1d-e053-2995a90aa804
    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 Sleepinal
    Proprietary Name Suffix n/a
    Non-Proprietary Name diphenhydramine hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name Blairex Laboratories, Inc.
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part338
    Listing Certified Through 2024-12-31

    Package

    NDC 50486-0616-32 (50486061632)

    NDC Package Code 50486-616-32
    Billing NDC 50486061632
    Package 4 BLISTER PACK in 1 CARTON (50486-616-32) / 8 CAPSULE in 1 BLISTER PACK
    Marketing Start Date 1999-10-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 111e891d-acd8-44f9-b958-09cb876d388c Details

    Revised: 11/2021