NDC 57815-031

First Aid Shot Therapy Cold Relief

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Menthol

First Aid Shot Therapy Cold Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by First Aid Beverages, Inc.. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Menthol.

Product ID57815-031_c4e9b0eb-f6f9-42a7-86dc-c2e6593eac70
NDC57815-031
Product TypeHuman Otc Drug
Proprietary NameFirst Aid Shot Therapy Cold Relief
Generic NameDextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Menthol
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFirst Aid Beverages, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; MENTHOL
Active Ingredient Strength20 mg/40mL; mg/40mL; mg/40mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57815-031-01

40 mL in 1 BOTTLE, PLASTIC (57815-031-01)
Marketing Start Date2015-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57815-031-01 [57815003101]

First Aid Shot Therapy Cold Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/40mL

OpenFDA Data

SPL SET ID:570f64a6-3486-466a-b98f-f91714a63afa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1667351

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