NDC 55315-004

Night Time Severe Cold and Cough

Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl

Night Time Severe Cold and Cough is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID55315-004_0d56bd18-734d-4960-bad8-3150ff544d36
NDC55315-004
Product TypeHuman Otc Drug
Proprietary NameNight Time Severe Cold and Cough
Generic NameAcetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2016-06-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFred's, Inc.
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55315-004-33

245.5 mL in 1 BOTTLE (55315-004-33)
Marketing Start Date2016-06-09
Marketing End Date2022-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-004-33 [55315000433]

Night Time Severe Cold and Cough SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-09

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:d773c939-b959-4dff-8a82-b085f2acb32c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298348
  • NDC Crossover Matching brand name "Night Time Severe Cold and Cough" or generic name "Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    55315-004Night Time Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    55319-977Night Time Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    59779-583Allergy and ColdAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    55301-464Allergy and Sinus HeadacheAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    33992-0464Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    55910-464Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    58602-120AuroFlu Flu and Sore Throat Warming ReliefAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    58602-161AuroFlu Night Time Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    58602-140AuroFlu Night Time Severe Cold and Cough Warming ReliefAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    58602-150AuroMucus Fast Maximum Night Time Cold and FluAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    64525-0562Best Choice Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCL
    59779-221CVS Pharmacy Nighttime Severe Cough and ColdAcetaminophen, Diphenhydramine HCL and Phenylephrine HCL
    64525-0566Family Dollar Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCL and Phenylephrine HCL
    10202-947Fast Maximum Night Time Cold and FluAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    64525-0558Meijer Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCL
    63868-764Quality Choice Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCL
    11822-5260severe cold and sinus relief PEAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    64525-0560Smart sense Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCl and Phenylephrine HCL
    36800-800TopCare Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCL and Phenylephrine HCL
    0363-0526Wal-PhedAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl
    64525-0564Western Family Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCL and Phenylephrine HCL
    67091-143WinCo Foods Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine HCL and Phenylephrine HCL

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