Home NDC 28595-802 HISTEX
Product NDC 28595-802
11-digit product format 285950802
Labeler code 28595
Product ID 28595-802_0e764061-e7a9-6701-e063-6394a90a489f
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 2014-03-04
Substance TRIPROLIDINE HYDROCHLORIDE
Active strength 2.5 mg/5mL
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIPROLIDINE HYDROCHLORIDE 2.5 mg/5mL
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 1490671 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 28595-802-08 HISTEX 237 mL in 1 BOTTLE SYRUP 237 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRIPROLIDINE HYDROCHLORIDE ACTIVE INGREDIENT YAN7R5L890 HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 TRIPROLIDINE ACTIVE MOIETY 2L8T9S52QM HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28595-802 HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240110_cc466d33-cf3e-4f1c-a794-6d3d79903adf.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 98 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 Marketing end Sample Exclude flag Status 28595-802-08 28595080208 237 mL in 1 BOTTLE (28595-802-08) 237 ml 2014-03-04 0000-00-00 No No Current