FDA.reportPublic FDA data

DiaSinc

Product NDC
59088-596
11-digit product format
590880596
Labeler code
59088
Product ID
59088-596_2385c911-b836-5c8c-e063-6394a90ad257
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
PureTek Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-24
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 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
DiaSinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039012Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9ba1ca8-8883-11bb-e053-2995a90a5846Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-596-16DiaSinc237 mL in 1 BOTTLE, SPRAYSPRAY2372

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-596-16ML - Milliliter59088-596fbe68773-ce5e-4b66-979d-0c76f2350a9012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-596DIASINC (BENZALKONIUM CHLORIDE) SPRAY [PURETEK CORPORATION]2Current NDC, 1 package rows20241004_d9ba1ca8-8883-11bb-e053-2995a90a5846.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 49 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b39e9-cf8e-3268-e063-6394a90a69c02025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462a1437-154c-0324-e063-6294a90a12662025-12-17WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLFamily Dollar Stores, Inc.15af30ec-f77d-2f5c-e063-6394a90a05802025-12-17WarningsExact identifier
application number: M003
Signature Select Isopropyl Alcohol Wipes (40 count)ISOPROPYL ALCOHOLBetter Living Brands LLCc9efcad4-f85c-4b10-9984-55549a4ff0262025-12-17WarningsExact identifier
application number: M003
finipil 4 men onlyBENZETHONIUM CHLORIDEEquibal, Inc.aba2e3e6-6047-416d-8ca3-44f1033671e32025-12-17WarningsExact identifier
application number: M003
finipil pro/elecBENZETHONIUM CHLORIDEEquibal, Inc.f68aa5db-7a4e-410f-8159-3356d9407d312025-12-17WarningsExact identifier
application number: M003
Made for MenBENZETHONIUM CHLORIDEEquibal, Inc.d12f748d-7dc5-4cd7-9718-ebb47171d58b2025-12-17WarningsExact identifier
application number: M003
QuickMendBENZETHONIUM CHLORIDEEquibal, Inc.9b0c85a4-9727-4940-a934-0b81a7c938cf2025-12-17WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSNd9ba1ca8-8883-11bb-e053-2995a90a58462
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCDd9ba1ca8-8883-11bb-e053-2995a90a58462
1039012benzalkonium chloride 0.13 % Topical SpraySYd9ba1ca8-8883-11bb-e053-2995a90a58462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-596-1659088059616237 mL in 1 BOTTLE, SPRAY (59088-596-16) 237 ml2023-03-24NoNoCurrent