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    NDC 50580-0608-08 Tylenol PM 500; 25 mg/1; mg/1 Details

    Tylenol PM 500; 25 mg/1; mg/1

    Tylenol PM is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.

    Product Information

    NDC 50580-0608
    Product ID 50580-608_f7569d66-9b31-9918-e053-6394a90a8302
    Associated GPIs
    GCN Sequence Number 003699
    GCN Sequence Number Description acetaminophen/diphenhydramine TABLET 500MG-25MG ORAL
    HIC3 B5S
    HIC3 Description ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE
    GCN 70221
    HICL Sequence Number 001861
    HICL Sequence Number Description ACETAMINOPHEN/DIPHENHYDRAMINE HCL
    Brand/Generic Generic
    Proprietary Name Tylenol PM
    Proprietary Name Suffix Extra Strength
    Non-Proprietary Name acetaminophen and diphenhydramine hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 500; 25
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
    Labeler Name Johnson & Johnson Consumer Inc.
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part343
    Listing Certified Through 2024-12-31

    Package

    NDC 50580-0608-08 (50580060808)

    NDC Package Code 50580-608-08
    Billing NDC 50580060808
    Package 1 BOTTLE in 1 CARTON (50580-608-08) / 50 TABLET, FILM COATED in 1 BOTTLE
    Marketing Start Date 2022-06-01
    NDC Exclude Flag N
    Pricing Information N/A