NDC 0031-8751

Robitussin Severe Multi-Symptom Cough Cold Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Robitussin Severe Multi-Symptom Cough Cold Flu is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 0031-8751_166bd240-05ec-4055-89c0-deddec03526e
• NDC: 0031-8751
• Product Type: Human Otc Drug
• Proprietary Name: Robitussin Severe Multi-Symptom Cough Cold Flu
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-05-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0031-8751-12

1 BOTTLE in 1 CARTON (0031-8751-12) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2015-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0031-8751-18 [00031875118]

Robitussin Severe Multi-Symptom Cough Cold Flu LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-05-01

NDC 0031-8751-12 [00031875112]

Robitussin Severe Multi-Symptom Cough Cold Flu LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-05-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL

OpenFDA Data

• SPL SET ID: 66360295-f364-479a-8b49-c12b21918279
• Manufacturer:
  • Richmond Division of Wyeth
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1116572

NDC Crossover Matching brand name "Robitussin Severe Multi-Symptom Cough Cold Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0031-8751	Robitussin Severe Multi-Symptom Cough Cold Flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0280-0061	Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0280-0507	Alka-Seltzer Plus Severe Sinus Cold and Cough	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
0113-7902	basic care daytime cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-4661	Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0363-9974	Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41520-984	COLD FLU and SORE THROAT RELIEF	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
41250-327	Cold, Flu, and Sore Throat	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
41250-569	daytime cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
37808-796	daytime severe	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
24385-066	good neighbor pharmacy cold	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0113-4500	good sense sever day time cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
47682-006	Green Guard Cough and Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
11822-1576	Maximum Strength Severe Sinus Pressure, Pain and Cough Relief	Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
47682-138	Medique Decorel Forte Plus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
0363-1940	severe cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-4150	Severe Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41520-985	Severe sinus Congestion Relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
11822-0940	severe vapor ice cold and flu relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
21130-811	signature care daytime severe cold and flu relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-581	topcare day time cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-948	topcare day time cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-747	Topcare Mucus Relief	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
36800-842	topcare mucus relief cold and flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-6300	Walgreen Severe Multi-Symptom Cough Cold Flu	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride