NDC 45014-158

Daytime Cough and Cold

Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride

Daytime Cough and Cold is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Accudial Pharmaceutical, Inc.. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID45014-158_97558c3c-84f5-4185-8462-a113bd2e3be8
NDC45014-158
Product TypeHuman Otc Drug
Proprietary NameDaytime Cough and Cold
Generic NameDextromethorphan Hydrobromide And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAccudial Pharmaceutical, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 45014-158-04

118 mL in 1 BOTTLE (45014-158-04)
Marketing Start Date2013-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45014-158-04 [45014015804]

Daytime Cough and Cold SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:e9e021cf-b8eb-4309-bf0b-a24334ba278e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1544873
  • NDC Crossover Matching brand name "Daytime Cough and Cold" or generic name "Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    45014-152Daytime Cough And ColdDextromethorphan Hydrobromide and Phenylephrine Hydrochloride
    45014-158Daytime Cough and ColdDextromethorphan Hydrobromide and Phenylephrine Hydrochloride
    50580-785Childrens SUDAFED PE Cold plus CoughDextromethorphan hydrobromide and Phenylephrine hydrochloride
    61941-1003Kids-EEZEDextromethorphan Hydrobromide and Phenylephrine Hydrochloride
    58605-308Maxi-Tuss JrDextromethorphan Hydrobromide and Phenylephrine Hydrochloride

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