FDA.reportPublic FDA data

Qore 24

Product NDC
42537-024
11-digit product format
425370024
Labeler code
42537
Product ID
42537-024_ff290e74-535d-49cb-9c29-84fcc4f1bfad
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Qore Systems LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
10 mg/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42537-024-012019-11-13C16284748780-197449f38-cb9c-f6ea-e053-dbdaa90aa703122ebe53-5fd7-4c35-91dd-b0ddc50aafa3
42537-024-022019-11-13C16284748780-197449f38-cb9c-f6ea-e053-dbdaa90aa703122ebe53-5fd7-4c35-91dd-b0ddc50aafa3
42537-024-032019-11-13C16284748780-197449f38-cb9c-f6ea-e053-dbdaa90aa703122ebe53-5fd7-4c35-91dd-b0ddc50aafa3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42537-024-01Qore 24Antimicrobial Hand Purifier236.59 mL in 1 BOTTLE, SPRAYSPRAY236.592
42537-024-02Qore 24Antimicrobial Hand Purifier10 mL in 1 BOTTLE, SPRAYSPRAY102
42537-024-03Qore 24Antimicrobial Hand Purifier59.15 mL in 1 BOTTLE, SPRAYSPRAY59.152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7QORE 24 ANTIMICROBIAL HAND PURIFIER (BENZALKONIUM CHLORIDE) SPRAY [QORE SYSTEMS LLC]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YQORE 24 ANTIMICROBIAL HAND PURIFIER (BENZALKONIUM CHLORIDE) SPRAY [QORE SYSTEMS LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MQORE 24 ANTIMICROBIAL HAND PURIFIER (BENZALKONIUM CHLORIDE) SPRAY [QORE SYSTEMS LLC]2
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEINACTIVE INGREDIENTIQ36O85WQ4QORE 24 ANTIMICROBIAL HAND PURIFIER (BENZALKONIUM CHLORIDE) SPRAY [QORE SYSTEMS LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RQORE 24 ANTIMICROBIAL HAND PURIFIER (BENZALKONIUM CHLORIDE) SPRAY [QORE SYSTEMS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42537-024QORE 24 ANTIMICROBIAL HAND PURIFIER (BENZALKONIUM CHLORIDE) SPRAY [QORE SYSTEMS LLC]2Legacy NDC, 3 package rows20120815_122ebe53-5fd7-4c35-91dd-b0ddc50aafa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052947benzalkonium chloride 0.1 % Topical SprayPSN122ebe53-5fd7-4c35-91dd-b0ddc50aafa32
1302627Qore-24 0.1 % Topical SprayPSN122ebe53-5fd7-4c35-91dd-b0ddc50aafa32
1302627benzalkonium chloride 1 MG/ML Topical Spray [Qore-24]SBD122ebe53-5fd7-4c35-91dd-b0ddc50aafa32
1052947benzalkonium chloride 1 MG/ML Topical SpraySCD122ebe53-5fd7-4c35-91dd-b0ddc50aafa32
1052947benzalkonium chloride 0.1 % Topical SpraySY122ebe53-5fd7-4c35-91dd-b0ddc50aafa32
1302627Qore-24 0.1 % Topical SpraySY122ebe53-5fd7-4c35-91dd-b0ddc50aafa32
1302627Qore-24 1 MG/ML Topical SpraySY122ebe53-5fd7-4c35-91dd-b0ddc50aafa32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42537-024-0142537002401236.59 mL in 1 BOTTLE, SPRAY236.59 mlHistorical
42537-024-024253700240210 mL in 1 BOTTLE, SPRAY10 mlHistorical
42537-024-034253700240359.15 mL in 1 BOTTLE, SPRAY59.15 mlHistorical