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 175 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	eb64750f-19ac-655f-e053-2995a90a33b5	2023-11-02	Warnings	Exact identifier application number: M012
Multi-Symptom Mapap Cold Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Proficient Rx LP	9bf81b26-38b4-486c-ae89-222119ce1a4f	2023-11-01	Warnings	Exact identifier application number: M012
Guaifenesin Syrup and Dextromethorphan	GUAIFENESIN SYRUP AND DEXTROMETHORPHAN	Natco Pharma USA LLC	ad9026f4-f0b6-4d02-aa44-f0460eeefc0e	2023-11-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HYDROCHLORIDE	Natco Pharma USA LLC	54b64354-ac10-42ff-a53d-96cef933a91a	2023-11-01	Warnings	Exact identifier application number: M012
children allergy relief dye free cherry	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5c6c1809-4c6f-4e8f-a5ae-9796e821d400	2023-11-01	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0903b222-1a44-64aa-e063-6294a90abba0	2023-10-31	Warnings	Exact identifier application number: M012
Ephrine Nose Drops	PHENYLEPHRINE HYDROCHLORIDE	Walgreens	b620eb9f-2caf-0942-e053-2a95a90ae48e	2023-10-31	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	204849d1-ac4b-4dbe-8769-fcb30291f880	2023-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	DAYTIME COLD AND FLU RELIEF	TopCo Associates, LLC	d592fbb8-d4bf-444e-982e-edf6fe97dce4	2023-10-31	Warnings	Exact identifier application number: M012
Nite Time Cold and Flu Relief	NITE TIME COLD AND FLU RELIEF	TopCo Associates, LLC	407dc4ae-882d-4a49-8884-ef048bb404cf	2023-10-31	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	Sheffield Pharmaceuticals LLC	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	2023-10-30	Warnings	Exact identifier application number: M012
Mucosa DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Magno-Humphries, Inc.	3a5533fb-1c83-4b95-9cd2-9be663d3ff5f	2023-10-27	Warnings	Exact identifier application number: M012
Mucosa Guifenesin	GUAIFENESIN	Magno-Humphries, Inc.	9d22c208-d0ae-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M012
DG Health Cough Drops Cherry Flavor	MENTHOL	Dollar General Corporation	c7a603d8-72fb-9626-e053-2995a90a09ea	2023-10-26	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Geri-Care Pharmaceutical Corp	92d90b41-0627-121e-e053-2995a90a2df1	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry	MENTHOL	Riclan S.A.	8e471265-3594-451a-8921-f0db474abe85	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Eucalyptus	MENTHOL	Riclan S.A.	1141593a-f3ba-4adf-b332-f9fcb0b5a013	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Honey Lemon	MENTHOL	Riclan S.A.	f6271e85-9ca2-41d3-9bff-a13670ac5b80	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Strawberry	MENTHOL	Riclan S.A.	da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457	2023-10-26	Warnings	Exact identifier application number: M012
DG Health Cough Drops Assorted Flavors	MENTHOL	Dollar General Corporation	c731d255-40f2-3cb3-e053-2a95a90a8877	2023-10-26	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