NDC 28595-804

HISTEX-DM

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride

HISTEX-DM is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Allegis Pharmaceuticals, Llc. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Triprolidine Hydrochloride.

Product ID28595-804_0c6c3162-37b5-4de2-8473-674cbe81449c
NDC28595-804
Product TypeHuman Otc Drug
Proprietary NameHISTEX-DM
Generic NameDextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2014-03-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAllegis Pharmaceuticals, LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active Ingredient Strength20 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 28595-804-16

473 mL in 1 BOTTLE (28595-804-16)
Marketing Start Date2014-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28595-804-16 [28595080416]

HISTEX-DM SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-03-19

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL

OpenFDA Data

SPL SET ID:836d062c-29f0-4fd7-b65c-771a3bbd52c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1492052
  • Medicade Reported Pricing

    28595080416 HISTEX-DM SYRUP

    Pricing Unit: ML | Drug Type:

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