NDC 55505-173

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; Doxylamine Succinate.

• Product ID: 55505-173_4361fc39-6bc7-4fde-866d-471d4c88f41f
• NDC: 55505-173
• Product Type: Human Otc Drug
• Proprietary Name: Safetussin PM
• Generic Name: Dextromethorphan Doxylamine Succinate
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Kramer Laboratories
• Substance Name: DEXTROMETHORPHAN; DOXYLAMINE SUCCINATE
• Active Ingredient Strength: 8 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55505-173-33

1 BOTTLE, PLASTIC in 1 CARTON (55505-173-33) > 118 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-02-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55505-173-33 [55505017333]

Safetussin PM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-02-09

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN	7.5 mg/5mL

OpenFDA Data

• SPL SET ID: 0f7e2c22-0c59-4027-ad61-6bdd048a605c
• Manufacturer:
  • Kramer Laboratories
• UNII:
  • V9BI9B5YI2
  • 7355X3ROTS
• 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