Home NDC 28595-809 HISTEX PD Drops New Formulation
Product NDC 28595-809
11-digit product format 285950809
Labeler code 28595
Product ID 28595-809_2b39e554-da95-1979-e063-6394a90a887a
Type HUMAN OTC DRUG
Nonproprietary name TRIPROLIDINE HYDROCHLORIDE
Dosage form SYRUP
Route ORAL
Labeler Allegis Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-13
Substance TRIPROLIDINE HYDROCHLORIDE
Active strength 1.25 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base HISTEX PD Drops New Formulation
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YAN7R5L890 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1926926 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 28595-809-30 HISTEX PD Drops New Formulation 1 in 1 CARTON SYRUP 1 3 28595-809-30 HISTEX PD Drops New Formulation 30 mL in 1 BOTTLE SYRUP 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28595-809 HISTEX PD DROPS NEW FORMULATION (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 3 Current NDC, 2 package rows 20250110_0c693f15-5d76-3dbf-e063-6294a90af9ac.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 28595-809-30 28595080930 1 BOTTLE in 1 CARTON (28595-809-30) / 30 mL in 1 BOTTLE 1 bottle 2023-12-13 No No Current