NDC 54859-544

Tusnel Pediatric

Dextromethorphan, Guiafenesin, Pseudoephedrine Hcl

Tusnel Pediatric is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

• Product ID: 54859-544_c018e718-f343-42eb-a069-a51a55c5b0cb
• NDC: 54859-544
• Product Type: Human Otc Drug
• Proprietary Name: Tusnel Pediatric
• Generic Name: Dextromethorphan, Guiafenesin, Pseudoephedrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2006-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Llorens Pharmaceutical International Division
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 54859-544-04

118 mL in 1 BOTTLE (54859-544-04)

• Marketing Start Date: 2006-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54859-544-16 [54859054416]

Tusnel Pediatric LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2006-01-01
• Inactivation Date: 2020-01-31

NDC 54859-544-04 [54859054404]

Tusnel Pediatric LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL

OpenFDA Data

• SPL SET ID: 82f447f6-4f1b-4f56-9d7d-ea02adeea88c
• Manufacturer:
  • Llorens Pharmaceutical International Division
• UNII:
  • 6V9V2RYJ8N
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1098911
• UPC Code:
  • 0054859544161

NDC Crossover Matching brand name "Tusnel Pediatric" or generic name "Dextromethorphan, Guiafenesin, Pseudoephedrine Hcl"

NDC	Brand Name	Generic Name
54859-602	Tusnel Pediatric	Guiafenesin, Pseudoephedrine HCl
54859-604	Tusnel Pediatric	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
54859-502	Tusnel	Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
54859-544	Tusnel	Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
54859-603	Tusnel DM	Dextromethorphan, Guiafenesin, Pseudoephedrine HCl