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 115 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Morning Star OTC	f4ff84b3-bb0c-4900-8ba4-6d1b90394782	2025-06-09	Warnings	Exact identifier application number: M012
Equate Kids Daytime Dex Cough Gels	DEXTROMETHORPHAN	Walmart	37269cd6-1528-9879-e063-6394a90a2b54	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	bdc35570-c8df-4797-a13e-7f2479ec42b7	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime and NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	f5764925-c586-40e4-8252-24d92389af01	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	2a29f0ed-d86b-4787-84e0-f7a8c5e7581f	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime and NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	7fa8e4ad-95cb-4905-90db-d53b3bc87c41	2025-06-09	Warnings	Exact identifier application number: M012
Vaporizing Steam Liquid	MEDICATED COUGH SUPPRESSANT	NeilMed Pharmaceuticals Inc.	36cf6218-adb8-9d8b-e063-6394a90a49a0	2025-06-05	Warnings	Exact identifier application number: M012
Geri-Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	7e2fb43c-a7f1-4c1d-a700-7c6510999c03	2025-06-05	Warnings	Exact identifier application number: M012
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR	Haleon US Holdings LLC	becb4025-b63e-f2ea-9d11-d51fdf4e5c13	2025-06-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCL STRAWBERRY FLAVOR	DIPHENHYDRAMINE HCL	Innovida Pharmaeutique Corporation	7eb709a5-c587-4f1d-bc2d-576d07a3a3bf	2025-06-04	Warnings	Exact identifier application number: M012
Children Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	TARGET CORPORATION	69d33f77-06e1-48fa-a516-892fdf11bb1c	2025-06-03	Warnings	Exact identifier application number: M012
oxymetazoline hydrochloride	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fd058e2b-5445-e416-e053-6394a90a611b	2025-06-03	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	36b1a7e0-c8b9-0890-e063-6394a90ab13a	2025-06-03	Warnings	Exact identifier application number: M012
COLD, FLU and SORE THROAT RELIEF	ACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MG	BETTER LIVING BRANDS, LLC	202d60a8-83da-5afc-e063-6394a90ad779	2025-05-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	TARGET CORPORATION	f935341f-1e33-d78e-e053-6294a90a348e	2025-05-30	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	AARNA USA INC.	365bb414-8425-a900-e063-6394a90aa887	2025-05-30	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	8559be55-8b00-4353-8e26-b5dff2ada806	2025-05-30	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walmart Inc.	35da8429-1f83-9e81-e063-6294a90a3515	2025-05-23	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORP	9dfef3dc-dbc8-659a-e053-2995a90a8c3b	2025-05-21	Warnings	Exact identifier application number: M012
Adult Tussin	GUAIFENESIN	Camber Consumer Care	896d2540-279a-4405-b176-acbff56303e5	2025-05-20	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