NDC 50580-194

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT

Acetaminophen And Dextromethorphan Hydrobromide

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

Product ID50580-194_5ce15358-3109-4722-8c14-2ef1526756c5
NDC50580-194
Product TypeHuman Otc Drug
Proprietary NameChildrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT
Generic NameAcetaminophen And Dextromethorphan Hydrobromide
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-06-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength160 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-194-01

1 BOTTLE in 1 CARTON (50580-194-01) > 120 mL in 1 BOTTLE
Marketing Start Date2017-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-194-01 [50580019401]

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT SUSPENSION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-06-26

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:e83f7911-22b4-4ffc-8f49-68f6acd2ebf5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370113
  • 1926565
  • UPC Code
  • 0300450169044
  • NDC Crossover Matching brand name "Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT" or generic name "Acetaminophen And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    63824-222Childrens DelsymAcetaminophen and Dextromethorphan Hydrobromide
    44237-043Childrens Novex Cold Plus Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE
    50580-194Childrens TYLENOLAcetaminophen and Dextromethorphan Hydrobromide
    63824-221DelsymAcetaminophen and Dextromethorphan Hydrobromide
    69423-972Vicks DayQuil HIGH BLOOD PRESSUREAcetaminophen and Dextromethorphan Hydrobromide

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