FDA.reportPublic FDA data

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
IngredientStrength
TRIPROLIDINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1490671Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc466d33-cf3e-4f1c-a794-6d3d79903adfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-802-08HISTEX237 mL in 1 BOTTLESYRUP2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-802-08ML - Milliliter28595-8023510fcc6-5786-45f1-9743-4135e56e412512014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-802HISTEX (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20240110_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 16 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.879a7804-f3d4-4a3d-bc92-b473499d6c952026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)95007785-ddf6-4386-af5f-84dac1066b402026-07-17WarningsExact identifier
application number: M012
BEST CHOICE No DripALLERGY SINUSBEST CHOICE (VALU MERCHANDISERS COMPANY)d5f95b56-8201-4d97-82ab-e23761bfe7202026-07-17WarningsExact identifier
application number: M012
Best Choice Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)7d19fdba-35b0-424a-ba11-315521d3256d2026-07-17WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)badb15ac-91e8-4962-96f5-beb2509775602026-07-17WarningsExact identifier
application number: M012
Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0839c07b-f692-4af1-85b8-da60fb281d492026-07-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWinCo Foods, LLC2cbf27b6-217c-46d8-89c9-e46f3668f0022026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)d86d53cd-75ce-4c40-83cb-ada9b77a76f62026-07-17WarningsExact identifier
application number: M012
LEADER Multi Symptom Flu Relief Daytime Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER2212cf9e-6944-4922-b5b5-1373cf10b2e12026-07-16WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATECVS PHARMACY06756130-1608-4ae6-9772-95a4549853a12026-07-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLOld East Main Co.7855033e-6a12-4cd8-b0a2-c5d69018d1172026-07-16Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline Hydrochloride 12-HourOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.34a79f8b-32b7-48db-a895-c942cc7952922026-07-16WarningsExact identifier
application number: M012
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC522e1e7f-98ed-c475-e063-6294a90a622c2026-07-16WarningsExact identifier
application number: M012
LEADER MS Flu Relief NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d2026-07-16WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC1bf4cd96-5800-434d-a0dc-e84c759ebb332026-07-16WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINWalgreens2ace231a-94c4-479d-bb26-454bd07b207b2026-07-16WarningsExact identifier
application number: M012
LEADER No DripALLERGY SINUS NASAL MISTCARDINAL HEALTH 110, LLC. DBA LEADERe7b2c1c1-6250-4af3-b131-22aced2b23d52026-07-16WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergen639a59b7-ccff-485e-a232-38b6808272292026-07-16WarningsExact identifier
application number: M012
Equate Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.30470a01-4d42-44c6-a017-d68bb74cdef72026-07-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490671triprolidine HCl 2.5 MG in 5 mL Oral SolutionPSNcc466d33-cf3e-4f1c-a794-6d3d79903adf4
1490671triprolidine hydrochloride 0.5 MG/ML Oral SolutionSCDcc466d33-cf3e-4f1c-a794-6d3d79903adf4
1490671triprolidine hydrochloride 2.5 MG per 5 ML Oral SolutionSYcc466d33-cf3e-4f1c-a794-6d3d79903adf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28595-802-0828595080208237 mL in 1 BOTTLE (28595-802-08) 237 ml2014-03-040000-00-00NoNoCurrent