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 173 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORP	0b1e230d-4354-bf61-e063-6394a90a2b2f	2023-12-09	Warnings	Exact identifier application number: M012
Phenylephrine HCl Maximum Strength	PHENYLEPHRINE HCL	A-S Medication Solutions	fcb769d0-aa45-48eb-acd0-2247b392f9fe	2023-12-09	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf915af-a016-0a46-e063-6394a90aacf5	2023-12-08	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and Flu	DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI	TARGET Corporation	0bf9c0df-7676-3060-e063-6394a90a16c7	2023-12-08	Warnings	Exact identifier application number: M012
Nazal	NAPHAZOLINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	4d4043f8-5ed3-4027-beb6-687db1308202	2023-12-06	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	8b4557d4-74a0-400f-ad7a-6d31473b3c67	2023-12-06	Warnings	Exact identifier application number: M012
Childrens Plus Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1598e6f8-08ee-4216-a5ab-76cad37b09a7	2023-12-06	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Fragile Skin Protectant	PETROLATUM	Welmedix LLC	6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf	2023-12-05	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash Relief	PETROLATUM, ZINC OXIDE	Welmedix LLC	551e6cce-7adc-4e98-baff-2703b83d7526	2023-12-05	Warnings	Exact identifier application number: M012
Stona-S	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1	2023-12-04	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	afc95c82-18da-487b-b4bb-51e0be0378da	2023-12-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	a14643a1-3d91-491a-88d6-22dccde97938	2023-12-04	Warnings	Exact identifier application number: M012
TopCare Day Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	14d53907-a4a2-4a0f-b2d6-33474945f9e1	2023-12-04	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Proficient Rx LP	62934d0f-b23d-4c03-9d60-a7bad41f9b42	2023-12-01	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	b1c849e5-8003-4fd3-811d-6a927523e353	2023-12-01	Warnings	Exact identifier application number: M012
Akin Expectorant Formula Strawberry Banana	GUAIFENESIN	Southern Sales & Service, Inc.	b63b0133-d2da-432b-a154-9e77535bbef9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM Strawberry Banana	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Southern Sales & Service, Inc.	7a81efd8-775d-455e-860f-f3e3b369a0a7	2023-11-29	Warnings	Exact identifier application number: M012
Akin	GUAIFENESIN	Southern Sales & Service, Inc.	bb2c9f21-6765-4286-bd71-de01cdf4c4e9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM	DEXTROMETHORPHAN, GUAIFENESIN	Southern Sales & Service, Inc.	1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a	2023-11-29	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Simpex Pharma Pvt. Ltd	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	2023-11-29	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