NDC 53145-008

Defensolito Children Syrup

Guaifenesin, Dextromethorphan Hbr

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

Product ID53145-008_1bc2e2b0-0502-4b4d-aa62-7594f0b7f9b0
NDC53145-008
Product TypeHuman Otc Drug
Proprietary NameDefensolito Children 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 NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength100 mg/15mL; mg/15mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53145-008-04

1 BOTTLE in 1 CARTON (53145-008-04) > 120 mL in 1 BOTTLE
Marketing Start Date2012-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53145-008-04 [53145000804]

Defensolito Children Syrup LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-21
Inactivation Date2020-01-31
Reactivation Date2020-02-27

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/15mL

OpenFDA Data

SPL SET ID:1077131e-c8b9-4f68-aa1e-191075cc97ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298228

    • NDC Crossover Matching brand name "Defensolito Children Syrup" or generic name "Guaifenesin, Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    53145-008Defensolito Children SyrupDefensolito Children 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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