HISTEX PD Drops New Formulation

Product NDC: 28595-809
11-digit product format: 285950809
Labeler code: 28595
Product ID: 28595-809_2b39e554-da95-1979-e063-6394a90a887a
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: 2023-12-13
Substance: TRIPROLIDINE HYDROCHLORIDE
Active strength: 1.25 mg/mL
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 PD Drops New Formulation
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIPROLIDINE HYDROCHLORIDE	1.25 mg/mL

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
1926926	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
0c693f15-5d76-3dbf-e063-6294a90af9ac	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
28595-809-30	HISTEX PD Drops New Formulation	1 in 1 CARTON	SYRUP	1		3
28595-809-30	HISTEX PD Drops New Formulation	30 mL in 1 BOTTLE	SYRUP	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
28595-809-30	ML - Milliliter	28595-809	4ab7a19c-b935-4c90-a32a-c4f05061c7f5	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
28595-809	HISTEX PD DROPS NEW FORMULATION (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]	3	Current NDC, 2 package rows	20250110_0c693f15-5d76-3dbf-e063-6294a90af9ac.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 95 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dristan 12 hr	OXYMETAZOLINE HYDROCHLORIDE	Foundation Consumer Brands	522876fe-a412-4ca8-bfad-a313e3cbc1af	2025-10-24	Warnings	Exact identifier application number: M012
Dimetapp Multi-Symptom Cold and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	178fe95b-e1ed-43b2-e063-6294a90a7a78	2025-10-24	Warnings	Exact identifier application number: M012
Menthol Drops Dollar General Severe 45ct	MENTHOL	Dollar General Corporation	c831d3d9-b910-40e6-bfdf-defe6850614d	2025-10-24	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	7d2f3292-bb73-41dc-9729-edb83670be1b	2025-10-24	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol 30ct	MENTHOL	R.L. ALBERT & SON, INC	b174e57c-4e4f-4842-b8f2-f1b067764a68	2025-10-24	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	17640528-c1f7-4881-ba86-bb3f488a952c	2025-10-24	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	33e259d6-b065-a677-e063-6394a90ab314	2025-10-23	Warnings	Exact identifier application number: M012
Severe Nighttime Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	1ec3fc79-4f38-439f-99be-646b82231aa5	2025-10-23	Warnings	Exact identifier application number: M012
Rycontuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories, Inc	41afb883-1158-9764-e063-6294a90a1712	2025-10-21	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE	CVS Pharmacy, Inc	1532ee21-e114-ded7-e063-6294a90ab025	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Method Pharmaceuticals	1538bf63-d020-3ba2-e063-6294a90aecc5	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Method Pharmaceuticals	389230e5-775e-5b0d-e054-00144ff88e88	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Method Pharmaceuticals, LLC	1539c3d4-d982-7d4e-e063-6394a90ad7d6	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Method Pharmaceuticals, LLC	312ce620-4841-7488-e054-00144ff88e88	2025-10-21	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	5a60c923-8bb7-427f-9636-08ed5474f71b	2025-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	97ed70a0-b692-4c12-90d6-72b3c87e554c	2025-10-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	311e2b6b-21cb-4b4c-a78d-a0732d29602f	2025-10-21	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	13910ea1-37dd-43bb-9fe8-e843f59201b7	2025-10-21	Warnings	Exact identifier application number: M012
SudoGest	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	d46577aa-7fd7-2130-6ed6-4b3f7562491f	2025-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Amerisource Bergen	d6f185b6-8538-4eac-98da-83760c34b488	2025-10-20	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
1926926	triprolidine HCl 1.25 MG in 1 mL Oral Solution	PSN	0c693f15-5d76-3dbf-e063-6294a90af9ac	3
1926926	triprolidine hydrochloride 1.25 MG/ML Oral Solution	SCD	0c693f15-5d76-3dbf-e063-6294a90af9ac	3
1926926	triprolidine HCl 1.25 MG per 1 mL Oral Solution	SY	0c693f15-5d76-3dbf-e063-6294a90af9ac	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
28595-809-30	28595080930	1 BOTTLE in 1 CARTON (28595-809-30) / 30 mL in 1 BOTTLE	1 bottle	2023-12-13	No	No	Current