NDC 55505-190

Safetussin PM

Dextromethorphan Doxylamine Succinate

Safetussin PM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Kramer Laboratories. The primary component is Dextromethorphan Hydrobromide; Doxylamine Succinate.

• Product ID: 55505-190_f68e2d21-632b-4e9f-ab3f-5c6dea20db0c
• NDC: 55505-190
• Product Type: Human Otc Drug
• Proprietary Name: Safetussin PM
• Generic Name: Dextromethorphan Doxylamine Succinate
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Kramer Laboratories
• 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 55505-190-36

240 mL in 1 BOTTLE, PLASTIC (55505-190-36)

• Marketing Start Date: 2015-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55505-190-36 [55505019036]

Safetussin PM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-07-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg/5mL

OpenFDA Data

• SPL SET ID: da5c218f-685c-4862-b532-9b525259663b
• Manufacturer:
  • Kramer Laboratories
• UNII:
  • V9BI9B5YI2
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1115333
  • 1115329
• UPC Code:
  • 0053076190366

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