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

Additional Listing Data#

Finished product
Yes
Brand name base
HISTEX PD Drops New Formulation
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIPROLIDINE HYDROCHLORIDE1.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYAN7R5L890
Rxcui1926926

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-809-30HISTEX PD Drops New Formulation1 in 1 CARTONSYRUP13
28595-809-30HISTEX PD Drops New Formulation30 mL in 1 BOTTLESYRUP303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-809-30ML - Milliliter28595-8094ab7a19c-b935-4c90-a32a-c4f05061c7f512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-809HISTEX PD DROPS NEW FORMULATION (TRIPROLIDINE HYDROCHLORIDE) SYRUP [ALLEGIS PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20250110_0c693f15-5d76-3dbf-e063-6294a90af9ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926926triprolidine HCl 1.25 MG in 1 mL Oral SolutionPSN0c693f15-5d76-3dbf-e063-6294a90af9ac3
1926926triprolidine hydrochloride 1.25 MG/ML Oral SolutionSCD0c693f15-5d76-3dbf-e063-6294a90af9ac3
1926926triprolidine HCl 1.25 MG per 1 mL Oral SolutionSY0c693f15-5d76-3dbf-e063-6294a90af9ac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
28595-809-30285950809301 BOTTLE in 1 CARTON (28595-809-30) / 30 mL in 1 BOTTLE1 bottle2023-12-13NoNoHistorical