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 117 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645	2025-05-07	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	2b962d87-6ff5-4c0f-8504-e5b61c940612	2025-05-05	Warnings	Exact identifier application number: M012
Cough and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID	CVS	2d13564a-e8d1-c357-e063-6394a90ad90e	2025-05-02	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33fe0e49-3de5-8afd-e063-6294a90a0ad5	2025-05-02	Warnings	Exact identifier application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy, Inc.	2d13964a-8cc4-f3dc-e063-6394a90aa105	2025-05-02	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	AARNA USA INC.	32c26835-f54e-d7e5-e063-6294a90ae1c0	2025-04-30	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33e6239b-364a-0e62-e063-6294a90a5047	2025-04-29	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	8296049c-72fc-4200-9d45-c8e377314cf2	2025-04-29	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Aurohealth LLC	70e1bd25-c32e-491f-b383-91d6f74957a0	2025-04-28	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CVS Pharmacy	70914691-220c-4fce-9ee1-61a51e8864bc	2025-04-26	Warnings	Exact identifier application number: M012
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	810ce630-41be-4e15-b64a-d70f63abaf62	2025-04-24	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	5f945975-224f-43eb-b129-a61e3b25c4bb	2025-04-22	Warnings	Exact identifier application number: M012
Walgreens Severe Honey Lemon Throat Drops	MENTHOL	Walgreens	334a9348-2a44-5c94-e063-6394a90ae956	2025-04-21	Warnings	Exact identifier application number: M012
meijer Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bd85bc3-e600-583d-e063-6294a90a7be1	2025-04-18	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	KROGER COMPANY	2be4a37b-44e1-8a8e-e063-6394a90a26a9	2025-04-17	Warnings	Exact identifier application number: M012
good neighbor pharmacy childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Amerisource Bergen	cde0fd43-771f-4528-bad2-5727efec5250	2025-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	729ab412-f30b-4ad1-9d8f-1a5e1c48b118	2025-04-16	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	9382c976-3067-4923-a38f-101d1c481e97	2025-04-11	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULES	Walmart Inc.	263d31c8-bdc2-a289-e063-6394a90a4aaa	2025-04-10	Warnings	Exact identifier application number: M012
CVS Wild Cherry Throat Drop	PECTIN	CVS	31f4b641-e9c0-786e-e063-6394a90aa253	2025-04-04	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