NDC 0295-1111

Safetussin DM

Dextromethorpan Guaifenesin

Safetussin DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Llc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 0295-1111_4f6894d9-3242-4bf1-b148-e8c2e920e2f8
• NDC: 0295-1111
• Product Type: Human Otc Drug
• Proprietary Name: Safetussin DM
• Generic Name: Dextromethorpan Guaifenesin
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Denison Pharmaceuticals, LLC.
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 10 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0295-1111-17

120 mL in 1 BOTTLE (0295-1111-17)

• Marketing Start Date: 2017-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0295-1111-28 [00295111128]

Safetussin DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-01
• Marketing End Date: 2019-11-11

NDC 0295-1111-17 [00295111117]

Safetussin DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL

OpenFDA Data

• SPL SET ID: 8e32e6cf-00e6-4e39-83a1-0d824fd44f74
• Manufacturer:
  • Denison Pharmaceuticals, LLC.
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1050511
  • 996520

NDC Crossover Matching brand name "Safetussin DM" or generic name "Dextromethorpan Guaifenesin"

NDC	Brand Name	Generic Name
0295-1111	Safetussin	Dextromethorpan Guaifenesin
55505-111	Safetussin	Dextromethorpan Guaifenesin
55505-189	Safetussin	Dextromethorpan Guaifenesin