NDC 0031-8753

Robitussin 12 Hour Cough Relief

Dextromethorphan Polistirex

Robitussin 12 Hour Cough Relief is a Oral Suspension, Extended Release in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Dextromethorphan Hydrobromide.

• Product ID: 0031-8753_16e55ae2-3c05-43e7-96f5-ae0faa7d08d6
• NDC: 0031-8753
• Product Type: Human Otc Drug
• Proprietary Name: Robitussin 12 Hour Cough Relief
• 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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 30 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0031-8753-03

1 BOTTLE in 1 CARTON (0031-8753-03) > 89 mL in 1 BOTTLE

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

NDC SPL Data Element Entries

NDC 0031-8753-03 [00031875303]

Robitussin 12 Hour Cough Relief 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: 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
• Manufacturer:
  • Richmond Division of Wyeth
• UNII:
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1659520
  • 1373045

NDC Crossover Matching brand name "Robitussin 12 Hour Cough Relief" or generic name "Dextromethorphan Polistirex"

NDC	Brand Name	Generic Name
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
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
11673-114	up and up 12 hour cough relief	dextromethorphan polistirex