NDC 0363-0494

Cough DM

Dextromethorphan Polistirex

Cough DM is a Oral Suspension, Extended Release in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Dextromethorphan Hydrobromide.

• Product ID: 0363-0494_389a099f-7869-47d7-8462-8c2bbaf1be48
• NDC: 0363-0494
• Product Type: Human Otc Drug
• Proprietary Name: Cough DM
• Generic Name: Dextromethorphan Polistirex
• Dosage Form: Suspension, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091135
• Labeler Name: Walgreen Company
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 30 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0363-0494-21

1 BOTTLE in 1 CARTON (0363-0494-21) > 89 mL in 1 BOTTLE

• Marketing Start Date: 2015-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0363-0494-28 [00363049428]

Cough DM SUSPENSION, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091135
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-05-20

NDC 0363-0494-21 [00363049421]

Cough DM SUSPENSION, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091135
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/5mL

OpenFDA Data

• SPL SET ID: be67fb34-6ecb-4b45-9a67-3f78f4af8e36
• Manufacturer:
  • Walgreen Company
• UNII:
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1373045

NDC Crossover Matching brand name "Cough DM" or generic name "Dextromethorphan Polistirex"

NDC	Brand Name	Generic Name
0363-0384	Cough DM	dextromethorphan polistirex
0363-0494	Cough DM	dextromethorphan polistirex
0363-0958	Cough DM	dextromethorphan polistirex
0904-6312	cough dm	dextromethorphan polistirex
11822-0384	Cough DM	dextromethorphan polistirex
11822-0494	Cough DM	dextromethorphan polistirex
11822-0958	Cough DM	Cough DM
17856-6312	cough dm	cough dm
30142-384	Cough DM	Cough DM
30142-494	cough dm	cough dm
30142-958	Cough DM	Cough DM
37012-384	Cough DM	Cough DM
37808-384	Cough DM	Cough DM
41250-384	Cough DM	Cough DM
41250-494	Cough DM	Cough DM
41250-958	Cough DM	Cough DM
42507-384	cough dm	cough dm
42507-958	Cough DM	Cough DM
56062-384	Cough DM	Cough DM
59779-384	Cough DM	Cough DM
59779-709	Cough DM	Cough DM
59779-958	Cough DM	Cough DM
0113-7384	basic care cough DM	dextromethorphan polistirex
0363-0899	childrens cough dm	Dextromethorphan polistirex
0031-8725	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8726	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0113-0384	good sense cough dm	dextromethorphan polistirex
0113-0958	Good Sense Cough DM	dextromethorphan polistirex
0031-8655	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8753	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8754	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8755	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
11673-114	up and up 12 hour cough relief	dextromethorphan polistirex