FDA.reportPublic FDA data

Antiseptic Wipes

Product NDC
58228-2404
11-digit product format
582282404
Labeler code
58228
Product ID
58228-2404_46015dbc-d596-c022-e063-6294a90a6bca
Type
HUMAN OTC DRUG
Nonproprietary name
Antiseptic Wipes
Dosage form
SWAB
Route
TOPICAL
Labeler
ProStat First Aid LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-08
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
Antiseptic Wipes
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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e120fed-3225-520b-e063-6394a90a9f9eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-2404-1Antiseptic Wipes50 in 1 BOXSWAB503
58228-2404-1Antiseptic Wipes1200 in 1 CASESWAB12003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-2404ANTISEPTIC WIPES SWAB [PROSTAT FIRST AID LLC]2Current NDC, 2 package rows20241127_0e120fed-3225-520b-e063-6394a90a9f9e.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 34 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLWalgreen Co.fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc2026-02-10Warnings, Adverse reactionsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.49e31509-d489-44be-e063-6394a90a97ef2026-02-10WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VMY IMPORTS USA LLC4a849c4f-9b96-6b20-e063-6394a90a34862026-02-10WarningsExact identifier
application number: M003
MedlineISOPROPYL ALCOHOLHy-Vee, Inc.4bbce274-1e62-0c6a-e063-6394a90af92f2026-02-10WarningsExact identifier
application number: M003
Everlit Care Products Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3331e2f1-c3d0-41fc-a792-be5dcdf4e24a2026-02-09WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.77a60360-8bb5-43e9-b7e4-f71d2d488c442026-02-09WarningsExact identifier
application number: M003
Everlit Care Products Sting ReliefISOPROPYL ALCOHOLEVERLIT GLOBAL INC.adfab206-b7de-4f6a-a864-edd946ea743d2026-02-09WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS IODINE PREP PADPOVIDONE-IODINEEVERLIT GLOBAL INC.5cbdb73d-333a-4244-a1c0-be430632f0ed2026-02-09WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLA-S Medication Solutions6b8834be-0235-4f7c-8d52-c2f6aa2d30492026-02-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESalado Sales Inc.78a46975-568a-4a88-8597-9603b8bbf9352026-02-06Warnings, Adverse reactionsExact identifier
application number: M003
70% RubbingISOPROPYL ALCOHOLWalgreens Co.6ad37d18-5c19-4b5f-8313-edd430f84fb02026-02-05Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.1473e6e4-dc5f-43d9-a249-111a181e3f762026-02-05Warnings, Adverse reactionsExact identifier
application number: M003
Aquarrelle Antibacterial Wipes 40BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.3584680e-71b0-23b6-e063-6294a90a69982026-02-05WarningsExact identifier
application number: M003
Aquarrelle Antibacterial Wipes 20BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.35865d33-a99f-1b37-e063-6394a90a00d22026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Cherry PopALCOHOLScent Theory Products LLC4a18b475-fd3b-10a3-e063-6294a90a4f472026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Ocean SplashALCOHOLScent Theory Products LLC4a18d7b2-94ca-7924-e063-6394a90af3d12026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Banana CremeALCOHOLScent Theory Products LLC4a18e8e0-43e3-70d8-e063-6294a90adf4b2026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Juicy PearALCOHOLScent Theory Products LLC4a18e8e0-43e5-70d8-e063-6294a90adf4b2026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Pink MelonALCOHOLScent Theory Products LLC4a18ec9c-d466-63c1-e063-6294a90a11222026-02-05WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPharmacy Value Alliance, LLC528011d7-8c6d-4940-bee1-52b39acef40d2026-02-05Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN0e120fed-3225-520b-e063-6394a90a9f9e3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD0e120fed-3225-520b-e063-6394a90a9f9e3
1038558benzalkonium chloride 0.13 % Topical ClothSY0e120fed-3225-520b-e063-6394a90a9f9e3
1038558benzalkonium chloride 0.13 % Topical SwabSY0e120fed-3225-520b-e063-6394a90a9f9e3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY0e120fed-3225-520b-e063-6394a90a9f9e3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY0e120fed-3225-520b-e063-6394a90a9f9e3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY0e120fed-3225-520b-e063-6394a90a9f9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-2404-1582282404011200 BOX in 1 CASE (58228-2404-1) / 50 POUCH in 1 BOX / .55 mL in 1 POUCH1200 box2024-01-08NoNoCurrent