NDC 0904-6980

Guaifenesin and Dextromethorphan Oral Solution

Guaifenesin Dextromethorphan Hydrobromide Oral Solution

Guaifenesin and Dextromethorphan Oral Solution is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

• Product ID: 0904-6980_9247ea9f-3df2-ef4c-e053-2995a90aab15
• NDC: 0904-6980
• Product Type: Human Otc Drug
• Proprietary Name: Guaifenesin and Dextromethorphan Oral Solution
• Generic Name: Guaifenesin Dextromethorphan Hydrobromide Oral Solution
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-09-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Major Pharmaceuticals
• Substance Name: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 200 mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0904-6980-72

10 TRAY in 1 CARTON (0904-6980-72) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE

• Marketing Start Date: 2019-09-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6980-72 [00904698072]

Guaifenesin and Dextromethorphan Oral Solution SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-20

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	200 mg/10mL

OpenFDA Data

• SPL SET ID: 9247ea9f-3df1-ef4c-e053-2995a90aab15
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 996520
• UPC Code:
  • 0309046980728
  • 0309046844709

NDC Crossover Matching brand name "Guaifenesin and Dextromethorphan Oral Solution" or generic name "Guaifenesin Dextromethorphan Hydrobromide Oral Solution"

NDC	Brand Name	Generic Name
0904-6844	Guaifenesin and Dextromethorphan Oral Solution	Guaifenesin Dextromethorphan hydrobromide Oral Solution
0904-6980	Guaifenesin and Dextromethorphan Oral Solution	Guaifenesin Dextromethorphan hydrobromide Oral Solution
62320-321	Cough and Chest Congestion DM	Guaifenesin Dextromethorphan hydrobromide Oral Solution