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 96 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
application number: M012
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)DIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.4157e680-37ac-eb4c-e063-6394a90a2a992025-10-17WarningsExact identifier
application number: M012
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED92c570ff-139f-49ff-a7bd-8a540ecc07c72025-10-17WarningsExact identifier
application number: M012
NoHist DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.6aafe912-28ff-442f-8e07-b3c5993ac9432025-10-16WarningsExact identifier
application number: M012
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact 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