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_5ec3818e-7c0d-54a8-e063-6394a90a7c1a
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: 2027-12-31
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: 2027-12-31

Active Ingredients#

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

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 167 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu Severe Cold relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	0d3b1bea-e2ca-4e07-8ae5-60627d230c96	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	adf33520-4689-4de2-b9d8-c201518e9d26	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	62f7fcb9-e31a-4634-b1c2-44a9567e3a61	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Caplets	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	8e22f6bc-33ce-4bb0-99be-7947aa21f60e	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Syrup	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	777d2ac7-e3cc-4513-8b6f-b90b2ff2c672	2024-03-07	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	4c6025ff-4982-4408-b077-75dd5f5b65b2	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	423fd5e6-5d90-4539-81e0-0ae23881ee3a	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	917df706-1982-4240-9f56-42d426b76cc5	2024-03-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	21a29998-29d6-4a36-a370-291d23bfb197	2024-03-05	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	3c7ef3cf-f7f9-42bc-bf20-e36954b9671f	2024-03-05	Warnings	Exact identifier application number: M012
QUALITY CHOICE NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	da06e994-6848-4c1e-9432-31de5e626ea4	2024-03-02	Warnings	Exact identifier application number: M012
QUALITY CHOICE DayTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	417c4fa9-6458-40d0-b22a-2415194e250f	2024-03-02	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Aurohealth LLC	8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2	2024-03-01	Warnings	Exact identifier application number: M012
APRODINE	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	A-S Medication Solutions	bbc268b8-fa66-4dc5-b935-f77ae39d28c8	2024-02-29	Warnings	Exact identifier application number: M012
XtraCare Vaporizing Chest Rub	CAMPHOR, MENTHOL	Rejoice International	c3e220d6-fff4-452f-99a9-bd701fc608a0	2024-02-28	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	ebbb2f4b-ba84-40ad-96f6-60225119a33b	2024-02-27	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	1c93c45d-1141-4599-83ba-6d3b38f9ffc4	2024-02-23	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