NDC 0031-8750

Robitussin Maximum Strength Severe Cough Plus Sore Throat

Acetaminophen, Dextromethorphan Hydrobromide

Robitussin Maximum Strength Severe Cough Plus Sore Throat is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Richmond Division Of Wyeth. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

• Product ID: 0031-8750_a4d2a12b-add6-46ad-bea2-1db943e232c3
• NDC: 0031-8750
• Product Type: Human Otc Drug
• Proprietary Name: Robitussin Maximum Strength Severe Cough Plus Sore Throat
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Richmond Division of Wyeth
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 650 mg/20mL; mg/20mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0031-8750-12

1 BOTTLE in 1 CARTON (0031-8750-12) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2017-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0031-8750-18 [00031875018]

Robitussin Maximum Strength Severe Cough Plus Sore Throat LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-04-10

NDC 0031-8750-12 [00031875012]

Robitussin Maximum Strength Severe Cough Plus Sore Throat LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-04-10

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL

OpenFDA Data

• SPL SET ID: 6a6f5da8-6433-4284-8df7-2d5b099b74dc
• Manufacturer:
  • Richmond Division of Wyeth
• UNII:
  • 362O9ITL9D
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1919076
  • 1919082

NDC Crossover Matching brand name "Robitussin Maximum Strength Severe Cough Plus Sore Throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
0031-8750	Robitussin Maximum Strength Severe Cough Plus Sore Throat	acetaminophen, dextromethorphan hydrobromide
0113-7101	Basic Care childrens cold and cough and sore throat	acetaminophen, dextromethorphan hydrobromide
69842-622	childrens cough and sore throat	acetaminophen, dextromethorphan Hydrobromide
11822-2023	childrens pain relief cold and cough and sore throat	acetaminophen, dextromethorphan hydrobromide
11523-0093	Coricidin HBP Maximum Strength Cold, Cough and Flu	acetaminophen, dextromethorphan hydrobromide
0363-0029	Cough and Sore Throat	Acetaminophen, Dextromethorphan hydrobromide
36800-893	Topcare childrens cold cough and sore throat	acetaminophen, dextromethorphan Hydrobromide
37000-027	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide