NDC 28595-803

HISTEX-PE

Phenylephrine Hydrochloride And Triprolidine Hydrochloride

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

Product ID28595-803_660edee9-4a95-4a0b-b951-c5283293c626
NDC28595-803
Product TypeHuman Otc Drug
Proprietary NameHISTEX-PE
Generic NamePhenylephrine Hydrochloride And Triprolidine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2014-03-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAllegis Pharmaceuticals, LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 28595-803-16

473 mL in 1 BOTTLE (28595-803-16)
Marketing Start Date2014-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28595-803-16 [28595080316]

HISTEX-PE SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-03-17
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL

OpenFDA Data

SPL SET ID:26c2117e-804e-4132-8707-fc0302fb9090
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094434
  • 1492064

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