NDC 45737-207

Bionel Pediatric

Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride

Bionel Pediatric is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Advanced Generic Corporation. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID45737-207_27ff6a28-8f3a-4a42-9cc9-0fe1afb85799
NDC45737-207
Product TypeHuman Otc Drug
Proprietary NameBionel Pediatric
Generic NameDextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2009-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAdvanced Generic Corporation
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 45737-207-16

473 mL in 1 BOTTLE (45737-207-16)
Marketing Start Date2009-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45737-207-16 [45737020716]

Bionel Pediatric LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:271c5895-25f5-4162-a278-6629b0ad03c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098911
  • NDC Crossover Matching brand name "Bionel Pediatric" or generic name "Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    45737-206BionelDextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride
    45737-207BionelDextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride

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