Home NDC 28595-809 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.
DailyMed Product Concepts# 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 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 175 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sinus Pressure plus Pain PE ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE RETAIL BUSINESS SERVICES , LLC. eb64750f-19ac-655f-e053-2995a90a33b5 2023-11-02 Warnings Exact identifier application number: M012 Multi-Symptom Mapap Cold Formula ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Proficient Rx LP 9bf81b26-38b4-486c-ae89-222119ce1a4f 2023-11-01 Warnings Exact identifier application number: M012 Guaifenesin Syrup and Dextromethorphan GUAIFENESIN SYRUP AND DEXTROMETHORPHAN Natco Pharma USA LLC ad9026f4-f0b6-4d02-aa44-f0460eeefc0e 2023-11-01 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HYDROCHLORIDE Natco Pharma USA LLC 54b64354-ac10-42ff-a53d-96cef933a91a 2023-11-01 Warnings Exact identifier application number: M012 children allergy relief dye free cherry DIPHENHYDRAMINE HCL A-S Medication Solutions 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 2023-11-01 Warnings Exact identifier application number: M012 Daytime and Nighttime Cherry Cold and Flu DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE TARGET CORPORATION 0903b222-1a44-64aa-e063-6294a90abba0 2023-10-31 Warnings Exact identifier application number: M012 Ephrine Nose Drops PHENYLEPHRINE HYDROCHLORIDE Walgreens b620eb9f-2caf-0942-e053-2a95a90ae48e 2023-10-31 Warnings Exact identifier application number: M012 pseudoephedrine hydrochloride PSEUDOEPHEDRINE HCL A-S Medication Solutions 204849d1-ac4b-4dbe-8769-fcb30291f880 2023-10-31 Warnings Exact identifier application number: M012 Daytime Cold and Flu Relief DAYTIME COLD AND FLU RELIEF TopCo Associates, LLC d592fbb8-d4bf-444e-982e-edf6fe97dce4 2023-10-31 Warnings Exact identifier application number: M012 Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TopCo Associates, LLC 407dc4ae-882d-4a49-8884-ef048bb404cf 2023-10-31 Warnings Exact identifier application number: M012 12 Hour Original Nasal Decongestant NASAL SPRAY Sheffield Pharmaceuticals LLC cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 2023-10-30 Warnings Exact identifier application number: M012 Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Magno-Humphries, Inc. 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f 2023-10-27 Warnings Exact identifier application number: M012 Mucosa Guifenesin GUAIFENESIN Magno-Humphries, Inc. 9d22c208-d0ae-8b6a-e053-2995a90ab90a 2023-10-27 Warnings Exact identifier application number: M012 DG Health Cough Drops Cherry Flavor MENTHOL Dollar General Corporation c7a603d8-72fb-9626-e053-2995a90a09ea 2023-10-26 Warnings Exact identifier application number: M012 Allergy Relief 4 Hour CHLORPHENIRAMINE MALEATE Geri-Care Pharmaceutical Corp 92d90b41-0627-121e-e053-2995a90a2df1 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry MENTHOL Riclan S.A. 8e471265-3594-451a-8921-f0db474abe85 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Eucalyptus MENTHOL Riclan S.A. 1141593a-f3ba-4adf-b332-f9fcb0b5a013 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon MENTHOL Riclan S.A. f6271e85-9ca2-41d3-9bff-a13670ac5b80 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Strawberry MENTHOL Riclan S.A. da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 2023-10-26 Warnings Exact identifier application number: M012 DG Health Cough Drops Assorted Flavors MENTHOL Dollar General Corporation c731d255-40f2-3cb3-e053-2a95a90a8877 2023-10-26 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# 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