NDC 35418-119

Cough Syrup DM

Guaifenesin, Dextromethorpham Hbr

Cough Syrup DM is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Zee Medical Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 35418-119_6061da5a-3e25-48b6-bd8a-9ad5ab18fc65
• NDC: 35418-119
• Product Type: Human Otc Drug
• Proprietary Name: Cough Syrup DM
• Generic Name: Guaifenesin, Dextromethorpham Hbr
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2012-06-12
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Zee Medical Inc
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 10 mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 35418-119-37

6 PACKET in 1 CARTON (35418-119-37) > 10 mL in 1 PACKET (35418-119-42)

• Marketing Start Date: 2012-06-12
• Marketing End Date: 2023-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35418-119-42 [35418011942]

Cough Syrup DM SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-06-12

NDC 35418-119-37 [35418011937]

Cough Syrup DM SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-06-12

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL

OpenFDA Data

• SPL SET ID: ab331af1-5edf-4f6b-9ee8-bf1d69d70e88
• Manufacturer:
  • Zee Medical Inc
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 996520
• UPC Code:
  • 0690689014568

NDC Crossover Matching brand name "Cough Syrup DM" or generic name "Guaifenesin, Dextromethorpham Hbr"

NDC	Brand Name	Generic Name
35418-119	Cough Syrup DM	Guaifenesin, Dextromethorpham HBr
42961-053	Cough Syrup DM	Guaifenesin, Dextromethorpham HBr