NDC 14505-488

Bisolvine Child

Guaifenesin, Dextromethorphan

Bisolvine Child is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Pharmalab Enterprises Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID14505-488_0f4bf76c-85e8-4941-91a8-ef14fedab1b7
NDC14505-488
Product TypeHuman Otc Drug
Proprietary NameBisolvine Child
Generic NameGuaifenesin, Dextromethorphan
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2010-02-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePharmalab Enterprises Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength100 mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 14505-488-04

120 mL in 1 BOTTLE, PLASTIC (14505-488-04)
Marketing Start Date2010-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14505-488-04 [14505048804]

Bisolvine Child LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE100 mg/5mL

OpenFDA Data

SPL SET ID:bb90c5c0-534c-4efe-8b1f-ca1b692e57c4
Manufacturer
UNII

NDC Crossover Matching brand name "Bisolvine Child" 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.