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 ID0031-8716_0477b6c8-f487-43ab-8a42-3bcc82369caf
NDC0031-8716
Product TypeHuman Otc Drug
Proprietary NameChildrens Robitussin Cough and Cold CF
Generic NameDextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2009-09-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL; mg/5mL
Pharm ClassesAdrenergic 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 FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0031-8716-12

1 BOTTLE in 1 CARTON (0031-8716-12) > 118 mL in 1 BOTTLE
Marketing Start Date2009-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8716-12 [00031871612]

Childrens Robitussin Cough and Cold CF LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-09-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:fcd0a8e0-ac2a-039a-be3c-534195d6bcfd
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0031-8716Childrens Robitussin Cough and Cold CFdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    24286-1546BACTIMICINA COUGH AND COLDDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    28595-906Duravent DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41163-738maximum strength mucus relief severe congestion and coughdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    41250-776Maximum Strength Mucus Relief Severe Congestion and Coughdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    49035-774Maximum Strength Mucus Relief Severe Congestion and Coughdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    49035-976Maximum Strength Mucus Relief Severe Congestion and Coughdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    41250-446Meijer Maximum Strength Severe Congestion and Coughdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    0031-8742Robitussin Peak Cold Multi-Symptom Colddextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    50066-308Tukol Children Cough and CongestionDextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    50066-534Tukol Cough And Cold Honey FlavorDextromethorphan Hydrobromide, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE
    50066-510Tukol Cough and CongestionDextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    50066-301Tukol Honey Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    11673-738Up and Up maximum Strength fast mucus reliefdextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

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