NDC 0295-5307

Safetussin PM

Dextromethorphan Doxylamine Succinate

Safetussin PM 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; Doxylamine Succinate.

• Product ID: 0295-5307_96c516e4-fdf3-07ae-e053-2a95a90ac5b0
• NDC: 0295-5307
• Product Type: Human Otc Drug
• Proprietary Name: Safetussin PM
• Generic Name: Dextromethorphan Doxylamine Succinate
• 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; DOXYLAMINE SUCCINATE
• Active Ingredient Strength: 8 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0295-5307-17

1 BOTTLE in 1 CARTON (0295-5307-17) > 120 mL in 1 BOTTLE

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

NDC SPL Data Element Entries

NDC 0295-5307-28 [00295530728]

Safetussin PM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-01
• Marketing End Date: 2019-11-07

NDC 0295-5307-17 [00295530717]

Safetussin PM 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	7.5 mg/5mL

OpenFDA Data

• SPL SET ID: 3d6e56ad-d31b-4ef6-9690-f18b1ee45664
• Manufacturer:
  • Denison Pharmaceuticals, LLC.
• UNII:
  • V9BI9B5YI2
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1115333
  • 1115329

NDC Crossover Matching brand name "Safetussin PM" or generic name "Dextromethorphan Doxylamine Succinate"

NDC	Brand Name	Generic Name
0295-5307	Safetussin	Dextromethorphan Doxylamine Succinate
55505-173	Safetussin	Dextromethorphan Doxylamine Succinate
55505-190	Safetussin	Dextromethorphan Doxylamine Succinate