HISTEX PD Drops New Formulation

Product NDC: 28595-809
Requested package NDC: 28595-809-30
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 104 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Unifirst First Aid Corporation	e8059137-efba-398c-e053-2a95a90a21f2	2025-09-08	Warnings	Exact identifier application number: M012
Medique Medi-Mucus	DEXTROMETHORPHAN HBR, GUAIFENESIN	Unifirst First Aid Corporation	f3bb862a-9cb8-f644-e053-2a95a90a5f4f	2025-09-08	Warnings	Exact identifier application number: M012
Physicians Care Cough and Sore Throat	MENTHOL	Acme United Corporation	4e02223d-f34b-333e-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application number: M012
Physicians Care Non-Drowsy Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Acme United	186ec543-1f23-75d6-e063-6294a90a46b9	2025-09-08	Warnings	Exact identifier application number: M012
PhysiciansCare Sinus Non-Drowsy	PHENYLEPHRINE HCL	Acme United Corporation	a6daf3ef-f386-4de4-b38e-d0b90c9ae62b	2025-09-08	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Multi-Symptom Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Acme United Corporation	fd101c27-6ba9-4cd3-baec-a354504c37a0	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Honey Lemon Cough Drop	MENTHOL 8.6 MG	Unifirst First Aid Corporation	8a94f090-61d6-4909-e053-2995a90aee38	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Cough Drop Relief	MENTHOL	Unifirst First Aid Corporation	0fc4cb11-8ff9-4eff-9588-c73eef4e0137	2025-09-08	Warnings	Exact identifier application number: M012
Multi-Symptom Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,	Unifirst First Aid Corporation	e6ea6faf-baff-a130-e053-2a95a90a085a	2025-09-08	Warnings	Exact identifier application number: M012
MEDIQUE Medikoff Drops	MENTHOL	Unifirst First Aid Corporation	0d6b4443-16a1-4851-bb03-d7407167551d	2025-09-08	Warnings	Exact identifier application number: M012
Medique Sugar Free Medikoff Drops	MENTHOL	Unifirst First Aid Corporation	92d13e19-4e7b-4565-970e-504abf02579a	2025-09-08	Warnings	Exact identifier application number: M012
Medique at Home Diphen	DIPHENHYDRAMINE HCL	Unifirst First Aid Corporation	b56d1966-efd7-56eb-e053-2995a90a89b5	2025-09-08	Warnings	Exact identifier application number: M012
Medique Chlorphen	CHLORPHENIRAMINE MALEATE	Unifirst First Aid Corporation	b3d5d161-8d4c-f1bb-e053-2a95a90a5bc5	2025-09-08	Warnings	Exact identifier application number: M012
Crane Safety Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Crane Safety LLC	968baa85-ce0e-0c3d-e053-2995a90ac03a	2025-09-08	Warnings	Exact identifier application number: M012
Thompson Cherry Cough Drops	MENTHOL	Thompson Safety LLC	c948f5b0-8491-6f9f-e053-2995a90a55fa	2025-09-08	Warnings	Exact identifier application number: M012
Medique Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e64c283b-0efa-0bfd-e053-2a95a90ab71d	2025-09-08	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	Walgreens	a99fdd49-0160-4a82-983b-fa56ab38ae76	2025-09-08	Warnings	Exact identifier application number: M012
Dye Free Wal Dryl Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	53e6f72d-15a4-4efe-8b1f-5753fed53df8	2025-09-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	40bfd631-51a4-4684-9ba0-a365d61da9bc	2025-09-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	f796ce1f-3077-4a0d-a41a-249c345ddb5f	2025-09-08	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