NDC 63102-102

ACTINEL PEDIATRIC

Dextromethorphan Hbr,guaifenesin,pseudoephedrine Hcl

ACTINEL PEDIATRIC is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Actipharma, Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID63102-102_c65a47f2-6adc-41bb-b24e-1bab4ae95593
NDC63102-102
Product TypeHuman Otc Drug
Proprietary NameACTINEL PEDIATRIC
Generic NameDextromethorphan Hbr,guaifenesin,pseudoephedrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-09-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameActipharma, Inc
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63102-102-16

474 mL in 1 BOTTLE (63102-102-16)
Marketing Start Date2014-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63102-102-16 [63102010216]

ACTINEL PEDIATRIC SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-09-24

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:6bb92d74-4893-40b8-af58-eb307155e876
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098911
  • UPC Code
  • 0663102102166
  • NDC Crossover Matching brand name "ACTINEL PEDIATRIC" or generic name "Dextromethorphan Hbr,guaifenesin,pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    63102-102ACTINEL PEDIATRICDextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl
    63102-101ACTINELDextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl

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