NDC 36800-958

TopCare Cough DM

Dextromethorphan Polistirex

TopCare Cough DM is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Dextromethorphan Hydrobromide.

• Product ID: 36800-958_73a7a38f-8da9-4f05-9432-017dfd694e9f
• NDC: 36800-958
• Product Type: Human Otc Drug
• Proprietary Name: TopCare Cough DM
• Generic Name: Dextromethorphan Polistirex
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-22
• Marketing End Date: 2022-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091135
• Labeler Name: Topco Associates LLC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 30 mg/5mL
• NDC Exclude Flag: N

Packaging

NDC 36800-958-21

1 BOTTLE in 1 CARTON (36800-958-21) > 89 mL in 1 BOTTLE

• Marketing Start Date: 2013-08-27
• Marketing End Date: 2022-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-958-21 [36800095821]

TopCare Cough DM SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA091135
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-27

NDC 36800-958-28 [36800095828]

TopCare Cough DM SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA091135
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-22

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/5mL

OpenFDA Data

• SPL SET ID: 93842397-7047-4ad6-9003-5e043ab5631b
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1373045

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

NDC	Brand Name	Generic Name
36800-494	TopCare Cough DM	TopCare Cough DM
36800-552	Topcare Cough DM	Topcare Cough DM
36800-958	TopCare Cough DM	TopCare Cough DM
36800-899	TopCare Cough DM	TopCare 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
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
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