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    NDC 00067-0105-08 Theraflu 650; 25 mg/30mL; mg/30mL Details

    Theraflu 650; 25 mg/30mL; mg/30mL

    Theraflu is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 00067-0105
    Product ID 0067-0105_c24b9489-208c-472b-8ae5-c6e86c12e04d
    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 Theraflu
    Proprietary Name Suffix Severe Cold Relief Nighttime
    Non-Proprietary Name Acetaminophen, Diphenhydramine HCl
    Product Type HUMAN OTC DRUG
    Dosage Form SYRUP
    Route ORAL
    Active Ingredient Strength 650; 25
    Active Ingredient Units mg/30mL; mg/30mL
    Substance Name ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name GlaxoSmithKline Consumer Healthcare Holdings (US) 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 00067-0105-08 (00067010508)

    NDC Package Code 0067-0105-08
    Billing NDC 00067010508
    Package 245.5 mL in 1 BOTTLE (0067-0105-08)
    Marketing Start Date 2023-12-01
    NDC Exclude Flag N
    Pricing Information N/A