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 10 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Best Health Maple Spice Cough Drops	MENTHOL	Bestco	58cfdacb-c713-220f-e063-6394a90acbfc	2026-08-11	Warnings	Exact identifier application number: M012
7 Select Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	7-ELEVEN	f9475972-0cbb-45c5-9e49-09569f1665a7	2026-08-11	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3	2026-08-10	Warnings	Exact identifier application number: M012
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2	2026-08-10	Warnings	Exact identifier application number: M012
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a9f01760-e335-4410-a9b8-8edce2841270	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed	GUAIFENESIN	Aldama Pharmaceuticals, Inc	38f37272-2084-a33b-e063-6294a90ac150	2026-08-10	Warnings	Exact identifier application number: M012
Chlorpheniramine Maleate	CHLORPHENIRAMINE MALEATE	PD-Rx Pharmaceuticals, Inc.	7a3452a2-930f-48b1-8c59-dbceb10b9c78	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed DM	DEXTROMETHORPHAN, GUAIFENESIN	Aldama Pharmaceuticals, Inc	396bf716-0f61-9563-e063-6394a90a171b	2026-08-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	eff114fe-fb15-48dd-b673-4d4d66406e69	2026-08-10	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	651b03a3-b85e-4028-a9f2-472bec16c8f4	2026-08-10	Warnings	Exact identifier application number: M012
NASAL	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	02a89765-2a75-470a-9fd6-8cce71dc19e9	2026-08-10	Warnings	Exact identifier application number: M012
WINCO Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WINCO FOODS, LLC	f34bfb71-2c81-44d0-a2a0-4d320c43c217	2026-08-07	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	11cac20e-9bb6-4e2d-8efd-4451f055c7b4	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	1d02b32a-e88d-4c70-b66d-7bdc22c25a43	2026-08-07	Warnings	Exact identifier application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	c1ecc56b-8052-4b0a-900a-dc93a24771bd	2026-08-07	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	bbf7d296-fa3d-43e5-984c-e9d2881a074d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	WinCo Foods, LLC	790d534a-0f40-495b-a815-67851ac3d20d	2026-08-07	Warnings	Exact identifier application number: M012
Extra Moisturizing Nasal Pump Mist Anti Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	46ebd262-c6a4-43ea-a7f6-506561bb3de4	2026-08-07	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	WINCO FOODS, LLC	e6afa830-6ce2-4abc-b5c9-3f5f156444df	2026-08-07	Warnings	Exact identifier application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTH	ACETAMINOPHEN, PHENYLEPHRINE HCL	CVS Pharmacy	a3b073b4-494c-4531-b08e-475c86ba321d	2026-08-07	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