HISTEX

Product NDC: 28595-802
Requested package NDC: 28595-802-08
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 71 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Nasal Decongestant	PSEUDOEPHEDRINE HCL	L. Perrigo Company	455b35b4-3969-411b-8036-887615d71e11	2025-12-21	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	Safeway Inc.	4a4f7f82-1b6c-7082-e054-00144ff88e88	2025-12-20	Warnings	Exact identifier application number: M012
Cherry Cough Drop	MENTHOL	Safeway Inc.	4a52c0c2-8659-2819-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
Signature Care Cherry Cough Drops	MENTHOL	Safeway	a733e905-af15-d3ea-e053-2a95a90aa7c3	2025-12-20	Warnings	Exact identifier application number: M012
Signature Care Honey Lemon Cough Drops	MENTHOL	Safeway	a742449f-c76b-2b91-e053-2a95a90ae4d2	2025-12-20	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenge	BENZOCAINE	TopCo	60b876e7-c642-5ce8-e053-2a91aa0abd6e	2025-12-20	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Topco Associates	366cc6b1-beff-29d2-e054-00144ff88e88	2025-12-20	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	TopCo Associates	3fef2117-7311-1e66-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Topco Associates	3ff1bf05-e407-3b67-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	Topco Associates	36727f0c-d6d2-28a3-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	Topco Associates	36824bee-607e-7095-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat Lozenges	BENZOCAINE	Topco Associates	7a00c771-9231-e877-e053-2a91aa0ac96e	2025-12-20	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	NUVICARE LLC	e25b440e-f389-443f-b333-c66ad1747158	2025-12-19	Warnings	Exact identifier application number: M012
Cold and Flu severe	ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL	Wal-Mart Stores Inc	9fca25dc-f63e-487a-8b7c-84d65ea51cb5	2025-12-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	a7d2eaee-484e-43aa-8ae3-0e050219383f	2025-12-19	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Publix	66d8e5f7-9766-57f3-e053-2991aa0a7e17	2025-12-19	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Publix	66e89fa3-ee09-1d16-e053-2a91aa0ae17c	2025-12-19	Warnings	Exact identifier application number: M012
Poly-Vent DM	DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	739329ae-0b62-4eab-a07d-867b5d3d61e0	2025-12-19	Warnings	Exact identifier application number: M012
Chest Congestion and Cough Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	ARMY AND AIR FORCE EXCHANGE SERVICE	89494a7c-cdbf-48f1-aaa9-2e57d4388a68	2025-12-19	Warnings	Exact identifier application number: M012
DayTime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	04f9134e-1311-4843-90db-9244b9e61e1d	2025-12-19	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