NDC 55505-111

Safetussin DM

Dextromethorpan Guaifenesin

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

• Product ID: 55505-111_4d8b36ff-ca03-40de-9979-82fcef6056d9
• NDC: 55505-111
• Product Type: Human Otc Drug
• Proprietary Name: Safetussin DM
• Generic Name: Dextromethorpan Guaifenesin
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2010-11-29
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Kramer Laboratories
• 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 55505-111-33

1 BOTTLE, PLASTIC in 1 CARTON (55505-111-33) > 118 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55505-111-12 [55505011112]

Safetussin DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-29
• Marketing End Date: 2013-08-13

NDC 55505-111-33 [55505011133]

Safetussin DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-02-10

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL

OpenFDA Data

• SPL SET ID: ac9f25a7-03cc-461b-af3e-8c16b7146a22
• Manufacturer:
  • Kramer Laboratories
• 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