FDA.reportPublic FDA data

HISTEX PDX Drops

Product NDC
28595-808
11-digit product format
285950808
Labeler code
28595
Product ID
28595-808_612ad2c9-4453-459c-97f6-8565e36b96c9
Type
HUMAN OTC DRUG
Nonproprietary name
TRIPROLIDINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-06-22
Marketing end
0000-00-00
Substance
TRIPROLIDINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct28595-808DDiscontinued by firm2026-08-17
excluded packagepackage28595-80828595-808-30DDiscontinued by firm2026-08-17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-808-30ML - Milliliter28595-808261a4b6c-d2d3-4128-b44a-410fb0a4ac7212017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-808HISTEX PDX DROPS (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]4Legacy NDC20240110_55a1a577-93af-4f4e-8858-430f4e2f6e56.zip