NDC 53145-039

Defensol Adult Syrup

Guaifenesin, Dextromethorphan Hbr

Defensol Adult Syrup is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Menper Distributors, Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID53145-039_2ec1220f-e6d6-4ac1-8d57-69e821126530
NDC53145-039
Product TypeHuman Otc Drug
Proprietary NameDefensol Adult Syrup
Generic NameGuaifenesin, Dextromethorphan Hbr
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-02-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMenper Distributors, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength20 mg/10mL; mg/10mL
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 53145-039-04

1 BOTTLE in 1 CARTON (53145-039-04) > 120 mL in 1 BOTTLE
Marketing Start Date2012-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53145-039-04 [53145003904]

Defensol Adult Syrup LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-21
Inactivation Date2020-01-31
Reactivation Date2020-02-04

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:62acff69-8c40-4a0e-8d56-be2cc14e3d45
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996520

    • NDC Crossover Matching brand name "Defensol Adult Syrup" or generic name "Guaifenesin, Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    53145-039Defensol Adult SyrupDefensol Adult Syrup
    47682-217Medique Guaicon DMSGuaifenesin, Dextromethorphan Hbr
    0904-6233MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBr
    11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    11822-7340Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    21130-933Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    37012-729Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    49035-825Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    11673-833Mucus Relief DM Extended ReleaseGuaifenesin, Dextromethorphan HBr
    0363-0437Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    0363-0733Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    0536-1213Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    37012-730Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    41250-633Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    41250-934Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    49035-824Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    50090-6020Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
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