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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cc466d33-cf3e-4f1c-a794-6d3d79903adf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
28595-802-08	ML - Milliliter	28595-802	3510fcc6-5786-45f1-9743-4135e56e4125	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 4 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	WAL-MART STORES INC	888bd90a-a059-4814-bd65-6b735ecfaf3a	2026-08-31	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime and Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	49a98411-aa5a-6de3-e063-6294a90a148f	2026-08-31	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	Sixarp, LLC	5a5a6917-9fb5-e6ca-e063-6394a90af9dc	2026-08-31	Warnings	Exact identifier application number: M012
Zicam Intense Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	d916f7ff-84b7-57ef-e053-2995a90a3efa	2026-08-31	Warnings	Exact identifier application number: M012
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-31	Warnings	Exact identifier application number: M012
Dextromethorphan HBr	DEXTROMETHORPHAN HBR	BIONPHARMA INC.	5a5dde85-8785-8149-e063-6294a90a4d57	2026-08-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Sixarp, LLC	5a5e2458-bab0-4931-e063-6394a90ad606	2026-08-31	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF	DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL	Reckitt Benckiser LLC	8d670d91-9e22-45b9-b568-5b62c2133d32	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	67849e09-2056-4013-98b1-d003ed3250a2	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	Akron Pharma Inc.	3b023b91-e703-4599-9864-96d8c328b45c	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion	GUAIFENESIN	Akron Pharma Inc.	ac874a31-5556-4669-937f-dcb52aaecd8a	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	e0ce4287-bfa1-4413-97c8-4fe2e39bda36	2026-08-31	Warnings	Exact identifier application number: M012
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	24173e77-92ec-4a87-a471-d6867837c180	2026-08-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	69af44c2-390c-4223-889a-d5555aef5778	2026-08-28	Warnings	Exact identifier application number: M012
Tussin DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	432d4833-2eaf-4f7c-b6b4-41043a6b7e2a	2026-08-28	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	93753885-6add-462c-9df8-b0a1b9ce36c9	2026-08-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Your Military Exchanges	13fcc43c-bdda-4b65-b6d7-23b39e683651	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M012
Multi-Symptom Allergy	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreen Company	5170c450-989d-44fa-ab38-86c78feae3b6	2026-08-28	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	54cbbc5f-908b-47b2-b37f-3646354d3568	2026-08-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YAN7R5L890	TRIPROLIDINE HYDROCHLORIDE	6138-79-0	TRIPROLIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490671	triprolidine HCl 2.5 MG in 5 mL Oral Solution	PSN	cc466d33-cf3e-4f1c-a794-6d3d79903adf	4
1490671	triprolidine hydrochloride 0.5 MG/ML Oral Solution	SCD	cc466d33-cf3e-4f1c-a794-6d3d79903adf	4
1490671	triprolidine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	cc466d33-cf3e-4f1c-a794-6d3d79903adf	4

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