Antiseptic Wipes

Product NDC
58228-2011
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 94 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
application number: M003
Mentholatum Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEThe Mentholatum Company365c93bc-2299-4e69-ba3a-69414bfe78d72024-12-13WarningsExact identifier
application number: M003
Curaplex Alcohol Prep PadISOPROPYL ALCOHOLSarnova, Inc.da1a4baa-05eb-4a75-82bb-39c547daef642024-12-12WarningsExact identifier
application number: M003
Foaming Hand SanitizerALCOHOLEmpack Spraytech Inc.8bb072f2-9cd4-499d-9d7f-7166451b8f202024-12-12WarningsExact identifier
application number: M003
Extra Stength Hand Sanitizer Zytec Germ BusterALCOHOL 80%W/WEmpack Spraytech Inc.da854195-3a50-4fae-a5ea-183bf524c9732024-12-12WarningsExact identifier
application number: M003
Zytec Hand Sanitizer Wipes 80% w/w AlcoholALCOHOLEmpack Spraytech Inc.ab86fd0c-40cd-0bb6-e053-2a95a90a76e22024-12-12WarningsExact identifier
application number: M003
Dermoplast Kids First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLC.29a18018-5214-4080-ac40-e646319e95ce2024-12-12WarningsExact identifier
application number: M003
New Skin BandageBENZETHONIUM CHLORIDEAdvantice Health, LLC.5846f414-8329-4034-b99f-92721bdb3d142024-12-12WarningsExact identifier
application number: M003
CVS Hand SanitizerALCOHOLCVSb5faeb31-67c7-2000-e053-2995a90a14092024-12-10WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC8d1a5c98-8169-4f40-8601-a6f6bbbbebe72024-12-09WarningsExact identifier
application number: M003
NEXXGEN 91% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC12b8c85a-da0c-47a1-9531-c9f2858c4f312024-12-09WarningsExact identifier
application number: M003
NEXXGEN 91% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLC609267da-3ee6-4bd3-aecf-610d9047774c2024-12-09WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSarnova, Inc.62be13a6-da24-4ab0-b0f4-f2894324c20c2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Globalb84075db-be0c-4265-b262-825bc6ade9d82024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global47276148-08e5-400e-94ac-d2d9db423b512024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2998b2bd-6208-4cb4-982b-0ffb97d7d75d2024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.68003c71-5959-476f-b252-1f131e9305e22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc22024-12-05WarningsExact 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