NDC 0031-8716

Childrens Robitussin Cough and Cold CF

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Childrens Robitussin Cough and Cold CF 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 Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 0031-8716_0477b6c8-f487-43ab-8a42-3bcc82369caf
• NDC: 0031-8716
• Product Type: Human Otc Drug
• Proprietary Name: Childrens Robitussin Cough and Cold CF
• Generic Name: Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2009-09-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL; mg/5mL
• 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 0031-8716-12

1 BOTTLE in 1 CARTON (0031-8716-12) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2009-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0031-8716-12 [00031871612]

Childrens Robitussin Cough and Cold CF LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-09-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL

OpenFDA Data

• SPL SET ID: fcd0a8e0-ac2a-039a-be3c-534195d6bcfd
• Manufacturer:
  • Richmond Division of Wyeth
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1370205

NDC Crossover Matching brand name "Childrens Robitussin Cough and Cold CF" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0031-8716	Childrens Robitussin Cough and Cold CF	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
24286-1546	BACTIMICINA COUGH AND COLD	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
28595-906	Duravent DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-738	maximum strength mucus relief severe congestion and cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
41250-776	Maximum Strength Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
49035-774	Maximum Strength Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
49035-976	Maximum Strength Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
41250-446	Meijer Maximum Strength Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
0031-8742	Robitussin Peak Cold Multi-Symptom Cold	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
50066-308	Tukol Children Cough and Congestion	Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
50066-534	Tukol Cough And Cold Honey Flavor	Dextromethorphan Hydrobromide, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE
50066-510	Tukol Cough and Congestion	Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
50066-301	Tukol Honey Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
11673-738	Up and Up maximum Strength fast mucus relief	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride