FDA.reportPublic FDA data

HISTEX-DM

Product NDC
28595-804
11-digit product format
285950804
Labeler code
28595
Product ID
28595-804_0e764fe3-cd4a-71c8-e063-6394a90afa31
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-19
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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-DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL
TRIPROLIDINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1492052Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
836d062c-29f0-4fd7-b65c-771a3bbd52c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-804-16HISTEX-DM473 mL in 1 BOTTLESYRUP4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-804-16ML - Milliliter28595-804911a3eb3-2eac-4bc7-9725-7a5efede853012014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890HISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-804HISTEX-DM (DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20240110_836d062c-29f0-4fd7-b65c-771a3bbd52c4.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
application number: M012
Broncomiel AdultsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509c61d3-ae16-be5c-e063-6294a90a68da2026-04-29WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINTOP CARE (Topco Associates LLC)aa1eb90c-e565-455f-8978-6f2f9e00a8142026-04-29WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DM adultDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLCe1280355-da81-489f-9bd2-ffea9a68010c2026-04-29WarningsExact identifier
application number: M012
Mucus Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC7b095ec5-9951-4491-9b68-7ac0a7f100532026-04-29WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOP CARE (Topco Associates LLC)98dd0ba6-0109-46b2-92df-11a0309842402026-04-28WarningsExact identifier
application number: M012
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1492052dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 5 mL Oral SolutionPSN836d062c-29f0-4fd7-b65c-771a3bbd52c44
1492052dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML / triprolidine hydrochloride 0.5 MG/ML Oral SolutionSCD836d062c-29f0-4fd7-b65c-771a3bbd52c44
1492052dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 5 ML Oral SolutionSY836d062c-29f0-4fd7-b65c-771a3bbd52c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28595-804-1628595080416473 mL in 1 BOTTLE (28595-804-16) 473 ml2014-03-190000-00-00NoNoCurrent