FDA.reportPublic FDA data

Antiseptic Wipes

Product NDC
58228-2011
Requested package NDC
58228-2011-1
11-digit product format
582282011
Labeler code
58228
Product ID
58228-2011_46018a36-87ec-fd5a-e063-6294a90af538
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
0e11238b-e5f2-075f-e063-6394a90aa825Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-2011-1Antiseptic Wipes480 in 1 CASESWAB4803
58228-2011-1Antiseptic Wipes20 in 1 BOXSWAB203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-2011ANTISEPTIC WIPES SWAB [PROSTAT FIRST AID LLC]2Current NDC, 2 package rows20241127_0e11238b-e5f2-075f-e063-6394a90aa825.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 50 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
application number: M003
DEYODISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.b147ed5b-ab6e-ca00-e053-2a95a90ae01a2025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC1ea56ac9-4fc2-41c0-adda-5a2c55bef6962025-12-10WarningsExact identifier
application number: M003
BIOCENCEEUCALYPTOL THYMOLBio-Germ Protection LLC847b9edc-74e6-43fd-83cd-43e6712780c62025-12-10WarningsExact identifier
application number: M003
The Pharma-C Company 70 Isopropyl Alcohol PadsISOPROPYL ALCOHOLKleen Test Products Corporationc5df867b-1b8d-4e38-8c32-7d528b9825902025-12-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.bf399508-bd29-0d90-e053-2995a90a067f2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb351a-06fb-8222-e053-2a95a90aadbf2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcead234-bb98-1ee8-e053-2a95a90a31862025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsExact identifier
application number: M003
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceb9358-663c-3c70-e053-2995a90a35242025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced08e7-a0bc-1328-e053-2995a90afb262025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dcec13da-586c-6e7e-e053-2a95a90a6cd12025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
application number: M003
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
application number: M003
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
application number: M003
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
application number: M003
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN0e11238b-e5f2-075f-e063-6394a90aa8253
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD0e11238b-e5f2-075f-e063-6394a90aa8253
1038558benzalkonium chloride 0.13 % Topical ClothSY0e11238b-e5f2-075f-e063-6394a90aa8253
1038558benzalkonium chloride 0.13 % Topical SwabSY0e11238b-e5f2-075f-e063-6394a90aa8253
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY0e11238b-e5f2-075f-e063-6394a90aa8253
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY0e11238b-e5f2-075f-e063-6394a90aa8253
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY0e11238b-e5f2-075f-e063-6394a90aa8253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-2011-158228201101480 BOX in 1 CASE (58228-2011-1) / 20 POUCH in 1 BOX / .55 mL in 1 POUCH480 box2024-01-08NoNoCurrent