NDC 52083-678

G-TRON PED

Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl

G-TRON PED is a Oral Solution 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: 52083-678_7d8d222b-b7a2-4165-b432-d400969ec490
• NDC: 52083-678
• Product Type: Human Otc Drug
• Proprietary Name: G-TRON PED
• Generic Name: Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl
• Dosage Form: Solution
• 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: 15 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52083-678-16

474 mL in 1 BOTTLE (52083-678-16)

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

NDC SPL Data Element Entries

NDC 52083-678-16 [52083067816]

G-TRON PED SOLUTION

• 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	15 mg/5mL

OpenFDA Data

• SPL SET ID: 75cd3241-e571-4b50-b03a-1715dc747825
• Manufacturer:
  • Kramer Novis
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1372451
• UPC Code:
  • 0352083678165

NDC Crossover Matching brand name "G-TRON PED" 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