NDC 63868-374

Childrens Multi-Symptom Cold Plus Dye-Free

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Childrens Multi-Symptom Cold Plus Dye-Free is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Quality Choice (chain Drug Marketing Association). The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID63868-374_ab5fc86e-c83a-4392-a45c-3ccc9bd52e10
NDC63868-374
Product TypeHuman Otc Drug
Proprietary NameChildrens Multi-Symptom Cold Plus Dye-Free
Generic NameAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2015-05-31
Marketing End Date2020-12-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameQUALITY CHOICE (Chain Drug Marketing Association)
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength160 mg/5mL; mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN

Packaging

NDC 63868-374-04

1 BOTTLE, PLASTIC in 1 BOX (63868-374-04) > 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2015-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63868-374-04 [63868037404]

Childrens Multi-Symptom Cold Plus Dye-Free SUSPENSION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-31
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:a2609950-edc3-4aa9-9da0-d41481209732
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113397
  • NDC Crossover Matching brand name "Childrens Multi-Symptom Cold Plus Dye-Free" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0280-1212Alka-Seltzer Plus Maximum Strength Cold and CoughAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0280-0023Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizzacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    0280-1560Alka-Seltzer Plus Severe Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-009Calmadol PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    56062-239childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    63868-374Childrens Multi-Symptom Cold PlusAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0363-0034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    11822-5047Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    15127-931Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    21130-034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    41520-704Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    46122-310Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55315-304Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55910-043Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    51467-007COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    55910-014DG Health cold multi symptomAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    58552-137Giltuss Childrens MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    58552-136Giltuss MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-001Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    49873-114Stonaacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    49873-113Stona-Sacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    36800-809topcare childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.