NDC 52083-641

Desgen Pediatric

Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl

Desgen Pediatric is a Oral Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 52083-641_c8298299-37cd-43d0-8514-592e11645226
• NDC: 52083-641
• Product Type: Human Otc Drug
• Proprietary Name: Desgen Pediatric
• Generic Name: Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl
• Dosage Form: Solution/ Drops
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-27
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Kramer Novis
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 52083-641-01

30 mL in 1 BOTTLE, DROPPER (52083-641-01)

• Marketing Start Date: 2014-01-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-641-01 [52083064101]

Desgen Pediatric SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-27

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: 12425c1b-8bdc-446b-83dd-95e05a4d9b8c
• Manufacturer:
  • Kramer Novis
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1095503

NDC Crossover Matching brand name "Desgen Pediatric" or generic name "Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
52083-641	Desgen	Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
52083-678	G-TRON	Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
52083-623	Tusslin	Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl