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 79 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	2771d699-3f70-4318-e063-6394a90a89cc	2025-12-09	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b	2025-12-09	Warnings	Exact identifier application number: M012
Circle K Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	9a32bc6d-0499-48fa-a6ad-702c8a28bf5f	2025-12-09	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	5015a380-a229-4eff-8e31-528065c6ed64	2025-12-09	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	caf59320-5b48-4533-bda9-7b03a2fde0b5	2025-12-09	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	30d41dc3-e2ef-4cad-b63c-d634bc749aa1	2025-12-09	Warnings	Exact identifier application number: M012
Walgreens Childrens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	327a7226-84b9-26d7-e063-6394a90a99b9	2025-12-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Meijer Distribution Inc	8ed5b802-a26e-45b4-a696-bc64dbac4733	2025-12-09	Warnings	Exact identifier application number: M012
dg health cold plus flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ff4a2f0a-d638-4ed2-8e05-2a52afbc4909	2025-12-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	24894484-b834-4b2f-b365-c95b5e30d8bf	2025-12-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Family Dollar (FAMILY WELLNESS)	2c431220-c61b-4ad5-9ad2-58ccaee2d1c3	2025-12-09	Warnings	Exact identifier application number: M012
Sinus PE Congestion Daytime Nighttime	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	9da77306-5098-4c79-845c-97ead849c84a	2025-12-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fdd0dadc-5313-4f6e-aef5-ca853efe5c4d	2025-12-08	Warnings	Exact identifier application number: M012
Mucolyte	GUAIFENESIN	Rising Pharma Holdings, Inc.	e4091aaf-44e3-4701-9986-aff248a2f1b8	2025-12-08	Warnings	Exact identifier application number: M012
Mucolyte DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rising Pharma Holdings, Inc.	c913d27d-bc00-4ace-9a5f-c55522e1cd1d	2025-12-08	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	American Sales	47f504d5-3ec5-5227-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
Sugar Free Menthol Cough Drops	MENTHOL	American Sales	4893ac0a-7769-5657-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	American Sales	45e891ea-2f2a-31b7-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenge	BENZOCAINE	American Sales	49248a40-1ca3-6dd1-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	American Sales	4896cbd1-57dd-1fc6-e054-00144ff8d46c	2025-12-07	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