NDC 63102-101

ACTINEL

Dextromethorphan Hbr,guaifenesin,pseudoephedrine Hcl

ACTINEL 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 ID: 63102-101_b8c3cfe5-6c95-4598-8732-110eab8daf66
• NDC: 63102-101
• Product Type: Human Otc Drug
• Proprietary Name: ACTINEL
• Generic Name: Dextromethorphan Hbr,guaifenesin,pseudoephedrine Hcl
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-24
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Actipharma, Inc
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63102-101-16

474 mL in 1 BOTTLE (63102-101-16)

• Marketing Start Date: 2014-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63102-101-16 [63102010116]

ACTINEL SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-09-24

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

OpenFDA Data

• SPL SET ID: db0cb6ae-0a4d-4232-805a-f3f3a058261f
• Manufacturer:
  • Actipharma, Inc
• UNII:
  • 6V9V2RYJ8N
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1098227

NDC Crossover Matching brand name "ACTINEL" or generic name "Dextromethorphan Hbr,guaifenesin,pseudoephedrine Hcl"

NDC	Brand Name	Generic Name
63102-101	ACTINEL	Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl
63102-102	ACTINEL PEDIATRIC	Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl