NDC 50580-785

Childrens SUDAFED PE Cold plus Cough

Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride

Childrens SUDAFED PE Cold plus Cough is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID50580-785_28c68f63-36fc-4a8c-a6a6-5aa1e504e2bb
NDC50580-785
Product TypeHuman Otc Drug
Proprietary NameChildrens SUDAFED PE Cold plus Cough
Generic NameDextromethorphan Hydrobromide And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2008-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-785-04

1 BOTTLE in 1 CARTON (50580-785-04) > 118 mL in 1 BOTTLE
Marketing Start Date2008-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-785-04 [50580078504]

Childrens SUDAFED PE Cold plus Cough SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2008-10-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:20e45243-3989-413a-bcf1-49d754ff2e44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827703
  • 1544873
  • NDC Crossover Matching brand name "Childrens SUDAFED PE Cold plus Cough" or generic name "Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-785Childrens SUDAFED PE Cold plus CoughDextromethorphan hydrobromide and Phenylephrine hydrochloride
    45014-152Daytime Cough And ColdDextromethorphan Hydrobromide and Phenylephrine Hydrochloride
    45014-158Daytime Cough and ColdDextromethorphan Hydrobromide and Phenylephrine Hydrochloride
    61941-1003Kids-EEZEDextromethorphan Hydrobromide and Phenylephrine Hydrochloride
    58605-308Maxi-Tuss JrDextromethorphan Hydrobromide and Phenylephrine Hydrochloride

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