NDC 36800-592

Topcare Mucus DM

Dextromethorphan Hbr, Guaifenesin

Topcare Mucus DM is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID36800-592_5a15fc6d-ba27-4a54-9af3-fe98ec1a4a37
NDC36800-592
Product TypeHuman Otc Drug
Proprietary NameTopcare Mucus DM
Generic NameDextromethorphan Hbr, Guaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-09-06
Marketing CategoryANDA / ANDA
Application NumberANDA207602
Labeler NameTopco Associates LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength60 mg/1; mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-592-30

1 BOTTLE in 1 CARTON (36800-592-30) > 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2022-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-592-66 [36800059266]

Topcare Mucus DM TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-06

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 mg/1

OpenFDA Data

SPL SET ID:60108084-4be9-4e8a-b354-9438e1694ebc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099074

    • NDC Crossover Matching brand name "Topcare Mucus DM" or generic name "Dextromethorphan Hbr, Guaifenesin"

    NDCBrand NameGeneric Name
    36800-592Topcare Mucus DMTopcare Mucus DM
    36800-735TopCare Mucus DMTopCare Mucus DM
    36800-219Topcare Mucus DMTopcare Mucus DM
    0113-7812basic care mucus dmdextromethorphan HBr, guaifenesin
    0031-2098Childrens Robitussin Elderberry Cough and Chest Congestion DMdextromethorphan HBr, guaifenesin
    0031-8760Childrens Robitussin Honey Cough and Chest Congestion DMdextromethorphan HBr, guaifenesin
    0363-0417Cough and Chest Congestion DMDextromethorphan HBr, Guaifenesin
    0363-0506Cough and Chest Congestion DMDextromethorphan HBr, Guaifenesin
    0113-0812good sense mucus dmdextromethorphan HBr, guaifenesin
    0113-0799Good Sense tussinDextromethorphan HBr, Guaifenesin
    0113-0578good sense tussin dmDextromethorphan HBr, Guaifenesin
    0113-0927Good Sense Tussin DM MaxDextromethorphan HBr, Guaifenesin
    0363-3380Mucus ReliefDextromethorphan HBr, Guaifenesin
    0363-0533Mucus Relief DMDextromethorphan HBr, Guaifenesin
    0363-0735Mucus Relief DMDextromethorphan HBr, Guaifenesin
    0904-6464robafenDextromethorphan HBr, Guaifenesin
    0031-2097Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMdextromethorphan HBr, guaifenesin
    0031-8756Robitussin Honey Maximum Strength Cough and Chest Congestion DMdextromethorphan hbr, guaifenesin
    0536-1184rugby coughDextromethorphan HBr, Guaifenesin
    0536-1199rugby mucus relief dmdextromethorphan HBr, guaifenesin
    0067-6089TherafluDextromethorphan HBr, Guaifenesin
    0113-0791tussin dmDextromethorphan HBr, Guaifenesin
    0363-0799wal tussinDextromethorphan HBr, Guaifenesin
    0363-0396wal tussin dmDextromethorphan HBr, Guaifenesin
    0363-0578wal tussin dmDextromethorphan HBr, Guaifenesin
    0363-0702wal tussin dm maxDextromethorphan HBr, Guaifenesin
    0363-1023wal tussin dm maxDextromethorphan HBr, Guaifenesin
    0363-0324Wal-Tussin DMDEXTROMETHORPHAN HBr, GUAIFENESIN
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