Search by Drug Name or NDC

    NDC 54859-0001-01 Dologesic 500; 1 mg/1; mg/1 Details

    Dologesic 500; 1 mg/1; mg/1

    Dologesic is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE.

    Product Information

    NDC 54859-0001
    Product ID 54859-001_8d50fa10-d47c-47ac-86d9-8a89e6308c9d
    Associated GPIs 43992002170325
    GCN Sequence Number 076023
    GCN Sequence Number Description acetaminophen/d-brompheniramin TABLET 500MG-1MG ORAL
    HIC3 B5S
    HIC3 Description ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE
    GCN 41262
    HICL Sequence Number 038226
    HICL Sequence Number Description ACETAMINOPHEN/DEXBROMPHENIRAMINE MALEATE
    Brand/Generic Brand
    Proprietary Name Dologesic
    Proprietary Name Suffix NF
    Non-Proprietary Name Acetaminophen, Dexbrompheniramine Maleate
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 500; 1
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
    Labeler Name Llorens Pharmaceutical International Division
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part343
    Listing Certified Through 2024-12-31

    Package

    NDC 54859-0001-01 (54859000101)

    NDC Package Code 54859-001-01
    Billing NDC 54859000101
    Package 100 TABLET in 1 BOTTLE (54859-001-01)
    Marketing Start Date 2016-04-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 974fc0d5-7a99-46fb-af38-b91240f728fa Details

    Revised: 12/2020