NDC 63868-291

Quality Choice Severe Cold and Cough Nighttime

Acetaminophen, Diphenhydramine, Phenylephrine

Quality Choice Severe Cold and Cough Nighttime is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Chain Drug Manufacturing Assn. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID63868-291_52efac03-8e1f-47a0-852e-23efdf600073
NDC63868-291
Product TypeHuman Otc Drug
Proprietary NameQuality Choice Severe Cold and Cough Nighttime
Generic NameAcetaminophen, Diphenhydramine, Phenylephrine
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2018-07-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameChain Drug Manufacturing Assn
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63868-291-06

6 PACKET in 1 CARTON (63868-291-06) > 1 POWDER, FOR SOLUTION in 1 PACKET
Marketing Start Date2018-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63868-291-06 [63868029106]

Quality Choice Severe Cold and Cough Nighttime POWDER, FOR SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-16

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:ce658dd5-b683-436e-b16b-0c06f6f87fd9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659960
  • NDC Crossover Matching brand name "Quality Choice Severe Cold and Cough Nighttime" or generic name "Acetaminophen, Diphenhydramine, Phenylephrine"

    NDCBrand NameGeneric Name
    63868-291Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
    59779-876CVS Health Nighttime Severe Cough and ColdACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
    68163-541Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
    0363-5410Nighttime Wal Flu Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
    67091-323Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE

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