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 158 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Day Cold and Flu and Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	TARGET CORPORATION	08ee56d1-b11d-3e36-e063-6294a90acd5f	2024-08-22	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE	TARGET CORPORATION	0fc523ce-55a7-6384-e063-6394a90aad3f	2024-08-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreens	8045aef9-22bc-4146-b494-dbb1ffef06df	2024-08-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5a2053d4-9c0d-4613-9cf5-0067173f3730	2024-08-16	Warnings	Exact identifier application number: M012
QUALITY CHOICE Long Acting Cough Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Marketing Association, Inc.	f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c	2024-08-16	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Padagis Israel Pharmaceuticals Ltd	458594e1-8d99-4de3-8923-2fd8ce2fc406	2024-08-16	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	54e0d57e-1f48-45e2-86b3-0e50775996f4	2024-08-15	Warnings	Exact identifier application number: M012
SanaTos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	1fc1408c-c540-39ab-e063-6394a90aa477	2024-08-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	489645ad-d7da-5f52-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6c949602-e0c8-40ce-8fb3-5147f406fa04	2024-08-14	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	3dbdf020-ca17-1197-e054-00144ff8d46c	2024-08-13	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	445e49a2-6ed0-434c-aaea-3ce14bc7df59	2024-08-12	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	d49b42ad-0ae0-48c9-adba-5fc2ced97764	2024-08-12	Warnings	Exact identifier application number: M012
RYMED	DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	c1d6e914-74cc-4cdf-9587-7eaaa4a386e5	2024-08-12	Warnings	Exact identifier application number: M012
WesTussin DM NF	WESTUSSIN DM NF	Westminster Pharmaceuticals, LLC	4e0f9f97-a31c-41ac-9d6c-d81efd20fcef	2024-08-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	2f2a2864-af11-4240-bdad-a54aca58d01b	2024-08-07	Warnings	Exact identifier application number: M012
Cold plus Flu Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0199aea2-a9c1-4c9d-8786-28b9dadc832e	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	32d1ce6e-2617-4b50-a9e6-2e1941465dff	2024-08-07	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	07362db5-a372-4463-af8b-06e8783ca865	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	1fb11d90-48bf-4baa-9b3a-5d64d81e3a06	2024-08-07	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