NDC 61787-516

Diabetic Tussin Nighttime Cold and Flu

Acetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl

Diabetic Tussin Nighttime Cold and Flu is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Akorn Consumer Health. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Diphenhydramine Hydrochloride.

Product ID61787-516_1b53dad2-fb10-4ee2-86f4-8e2bb9bd6280
NDC61787-516
Product TypeHuman Otc Drug
Proprietary NameDiabetic Tussin Nighttime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2020-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAkorn Consumer Health
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength650 mg/10mL; mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 61787-516-04

1 BOTTLE in 1 CARTON (61787-516-04) > 118 mL in 1 BOTTLE
Marketing Start Date2020-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61787-516-04 [61787051604]

Diabetic Tussin Nighttime Cold and Flu LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-02-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/10mL

OpenFDA Data

SPL SET ID:4d5e317f-0e32-4cdc-b56e-b792efa972f5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094131
  • NDC Crossover Matching brand name "Diabetic Tussin Nighttime Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    61787-452Diabetic Tussin Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
    61787-516Diabetic Tussin Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl

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