NDC 42213-161

Ultra Tuss DM

Guaifenesin Dextromethorphan Hbr

Ultra Tuss DM is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Ultra Seal Corporation. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

• Product ID: 42213-161_1074c6f9-8fb8-41d7-acaa-c8d5f4832369
• NDC: 42213-161
• Product Type: Human Otc Drug
• Proprietary Name: Ultra Tuss DM
• Generic Name: Guaifenesin Dextromethorphan Hbr
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2012-06-19
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Ultra Seal Corporation
• Substance Name: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 100 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42213-161-93

474 mL in 1 BOTTLE (42213-161-93)

• Marketing Start Date: 2012-06-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42213-161-93 [42213016193]

Ultra Tuss DM SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-06-19

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	100 mg/5mL

OpenFDA Data

• SPL SET ID: f069a80f-1320-4260-b5d7-c9e58b419d04
• Manufacturer:
  • Ultra Seal Corporation
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 996520
• UPC Code:
  • 0001500161932

NDC Crossover Matching brand name "Ultra Tuss DM" or generic name "Guaifenesin Dextromethorphan Hbr"

NDC	Brand Name	Generic Name
42213-161	Ultra Tuss DM	guaifenesin dextromethorphan HBr
42961-121	First Aid Direct Cough Relief DM	guaifenesin dextromethorphan HBr
42213-162	Ultra Tuss Safe	guaifenesin dextromethorphan HBr