NDC 63561-0128

FLU-MED NIGHTTIME SEVERE COLD and COUGH

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine

FLU-MED NIGHTTIME SEVERE COLD and COUGH is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Granulation Technology, Inc.. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID63561-0128_64a22640-eb30-0599-e053-2991aa0ad14b
NDC63561-0128
Product TypeHuman Otc Drug
Proprietary NameFLU-MED NIGHTTIME SEVERE COLD and COUGH
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2018-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGRANULATION TECHNOLOGY, INC.
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63561-0128-6

6 PACKET in 1 CARTON (63561-0128-6) > 1 POWDER, FOR SOLUTION in 1 PACKET
Marketing Start Date2018-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63561-0128-6 [63561012806]

FLU-MED NIGHTTIME SEVERE COLD and COUGH POWDER, FOR SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:0911ef0b-2ec4-4a78-b477-52700e453a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659960
  • NDC Crossover Matching brand name "FLU-MED NIGHTTIME SEVERE COLD and COUGH" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine"

    NDCBrand NameGeneric Name
    63561-1128end-a-fluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE
    63561-0128FLU-MEDACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE

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