NDC 53145-322

Bisolvine Children

Guaifenesin, Dextromethorphan

Bisolvine Children 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 ID53145-322_4f07b9ae-5e6b-41e7-afac-096a54a5a977
NDC53145-322
Product TypeHuman Otc Drug
Proprietary NameBisolvine Children
Generic NameGuaifenesin, Dextromethorphan
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2010-01-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMENPER DISTRIBUTORS INC.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength10 mg/15mL; mg/15mL
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 53145-322-04

1 BOTTLE in 1 CARTON (53145-322-04) > 120 mL in 1 BOTTLE
Marketing Start Date2010-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53145-322-04 [53145032204]

Bisolvine Children LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-01-18

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/15mL

NDC Crossover Matching brand name "Bisolvine Children" or generic name "Guaifenesin, Dextromethorphan"

NDCBrand NameGeneric Name
14505-488BisolvineGuaifenesin, Dextromethorphan
53145-321BisolvineGuaifenesin, Dextromethorphan
53145-322BisolvineGuaifenesin, Dextromethorphan
53145-325BisolvineGuaifenesin, Dextromethorphan

Trademark Results [Bisolvine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BISOLVINE
BISOLVINE
77826772 3780920 Live/Registered
ALPER HOLDINGS INC.
2009-09-15

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