NDC 58805-007

Cough and Congestion DM

Dextromethorphan And Guaifenesin

Cough and Congestion DM is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Agile Pharmachem. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 58805-007_4e88b254-c0b1-48bf-9ca5-b13a22118204
• NDC: 58805-007
• Product Type: Human Otc Drug
• Proprietary Name: Cough and Congestion DM
• Generic Name: Dextromethorphan And Guaifenesin
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2015-11-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Agile Pharmachem
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 10 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58805-007-75

7500 CARTON in 1 CAPSULE (58805-007-75) > 1 CAPSULE, LIQUID FILLED in 1 CARTON

• Marketing Start Date: 2015-11-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58805-007-75 [58805000775]

Cough and Congestion DM CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-11-08
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e
• Manufacturer:
  • Agile Pharmachem
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1111663

NDC Crossover Matching brand name "Cough and Congestion DM" or generic name "Dextromethorphan And Guaifenesin"

NDC	Brand Name	Generic Name
58805-007	Cough and Congestion DM	Dextromethorphan and Guaifenesin
63941-817	Cough and Congestion DM	Dextromethorphan Hydrobromide, Guaifenesin
76168-060	Cough and Congestion DM	Dextromethorphan and Guaifenesin