NDC 44237-043

Childrens Novex Cold Plus Cough Plus Sore Throat

Acetaminophen And Dextromethorphan Hydrobromide

Childrens Novex Cold Plus Cough Plus Sore Throat is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Herbion Pakistan (pvt.) Ltd. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

Product ID44237-043_854cfd53-2a12-40cd-82f5-d5370cb4da01
NDC44237-043
Product TypeHuman Otc Drug
Proprietary NameChildrens Novex Cold Plus Cough Plus Sore Throat
Generic NameAcetaminophen And Dextromethorphan Hydrobromide
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2020-03-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHerbion Pakistan (Pvt.) Ltd
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength160 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 44237-043-03

1 BOTTLE in 1 CARTON (44237-043-03) > 120 mL in 1 BOTTLE
Marketing Start Date2020-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44237-043-03 [44237004303]

Childrens Novex Cold Plus Cough Plus Sore Throat SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-21

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:7f631f45-06e4-4860-abb7-1e1b1e146035
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370113
  • NDC Crossover Matching brand name "Childrens Novex Cold Plus Cough Plus Sore Throat" or generic name "Acetaminophen And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    44237-043Childrens Novex Cold Plus Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE
    63824-222Childrens DelsymAcetaminophen 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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