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 54 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS Healthc8d4f3b3-166c-2411-e053-2a95a90abb4a2025-11-12WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)e3100877-6261-4502-8db8-d8ae3af6cd792025-11-12WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)c65ddc74-4666-457d-91bd-138143446bbe2025-11-12WarningsExact identifier
application number: M003
Dr Lift Antibacterial Hand SanitizerETHYL ALCOHOLSpa de Soleilaba006cd-18db-e42f-e053-2995a90a46072025-11-12WarningsExact identifier
application number: M003
Recovery Antiseptic Skin PrepCHLOROXYLENOLPURKLENZ FORMULATIONS INC.94c5ea07-6bdb-42c6-8ce0-0d0711bd70362025-11-12WarningsExact identifier
application number: M003
PurKlenzCHLOROXYLENOLPurKlenz Formulations Inc.9f1223a8-a256-46f0-b01d-01b32ca09d482025-11-12WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Lemon SorbetALCOHOLShenzhen Lantern Scicence Co.,Ltd.434d3071-802b-f598-e063-6394a90a622d2025-11-11WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Strawberry ShortcakeALCOHOLShenzhen Lantern Scicence Co.,Ltd.434d5f7c-f84d-d6f5-e063-6294a90aa6fe2025-11-11WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer PearALCOHOLShenzhen Lantern Scicence Co.,Ltd.434ddef3-fe48-138d-e063-6394a90afc912025-11-11WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd9884b7-6df3-5ece-e053-2a95a90ab20e2025-11-11WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd8643ef-dc83-8bc1-e053-2995a90a007b2025-11-11WarningsExact identifier
application number: M003
Betadine Solution SwabsticksPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.0707b259-52a4-4ae6-b176-d093865906e72025-11-11WarningsExact identifier
application number: M003
Walgreens Hand Sanitizer Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.435ca082-0b6b-c55e-e063-6294a90af56e2025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d514e-204a-118b-e063-6294a90aa8a62025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spider-manALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d939c-9bef-bf86-e063-6394a90a41422025-11-11WarningsExact identifier
application number: M003
Foaming Hand SanitizerHAND SANITIZERAmerican Chemical Systems II, LLC3085d595-68b7-4100-81c0-f0699a7609d62025-11-10WarningsExact identifier
application number: M003
Genuine First Aid Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.48867a79-4d21-4ba1-9cf9-7839352a4b7e2025-11-07WarningsExact identifier
application number: M003
Pocket NurseISOPROPYL ALCOHOLPocket Nurse Enterprises, LLC42ded32e-15d9-8b03-e063-6394a90ad6bc2025-11-06WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANITIZER MIX BERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5785f-a86b-47fb-e063-6294a90a73142025-11-05WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer Blue RaspberryALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5afab-e872-09e3-e063-6394a90abcc42025-11-05WarningsExact 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