FDA.reportPublic FDA data

BZK Antiseptic Wipe

Product NDC
59050-264
Requested package NDC
59050-264-01
11-digit product format
590500264
Labeler code
59050
Product ID
59050-264_09c4d16d-129e-7f9d-e063-6294a90a91b0
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Changzhou Maokang Medical Products Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-10
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
BZK Antiseptic Wipe
Listing expiration
2027-12-31

Active Ingredients#

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

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
fe5eb694-4b1b-4c47-95d5-6074155c438aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59050-264-01BZK Antiseptic Wipe1 in 1 POUCHCLOTH12
59050-264-01BZK Antiseptic Wipe0.34 g in 1 PATCHCLOTH0.342

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-264BZK ANTISEPTIC WIPE (BENZALKONIUM CHLORIDE) CLOTH [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]2Current NDC, Legacy NDC, 2 package rows20231111_fe5eb694-4b1b-4c47-95d5-6074155c438a.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 107 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyMedic Calendula GelCALENDULA OFFICINALIS FLOWERNantong Health & Beyond Hygienic Products Inc.0f0aa235-ac35-ac91-e063-6394a90a73fc2024-01-16WarningsExact identifier
application number: M003
MyMedic Oral Pain Relief GelBENZOCAINENantong Health & Beyond Hygienic Products Inc.0f0b6157-ec18-13ef-e063-6294a90a2e0c2024-01-16WarningsExact identifier
application number: M003
MyMedic Super SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.0f0c535d-8ff3-4799-e063-6394a90a70632024-01-16WarningsExact identifier
application number: M003
MyMedic Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0f0d1ba7-fe9c-8e0b-e063-6394a90a30812024-01-16WarningsExact identifier
application number: M003
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
application number: M003
Thompson Hand SanitizerETHYL ALCOHOLThompsondeada606-8a82-9eeb-e053-2a95a90a9e6d2024-01-16WarningsExact identifier
application number: M003
MyMedic Arnica GelARNICA MONTANANantong Health & Beyond Hygienic Products Inc.0ef8760d-27c0-7ece-e063-6294a90a68732024-01-15WarningsExact identifier
application number: M003
American Safety First Aid AntispeticHYDROGEN PEROXIDEOrazen Incea2fbdfe-1932-9fb4-e053-2a95a90a35632024-01-15WarningsExact identifier
application number: M003
First Aid AntispeticBENZALKONIUM CHLORIDEOrazen Incea2debcb-892c-339f-e053-2a95a90a4b182024-01-15WarningsExact identifier
application number: M003
Ever Ready First AidBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aide53f3bf5-25c0-2b86-e053-2a95a90a010f2024-01-15WarningsExact identifier
application number: M003
FIRST SHIELD First Aid AntisepticBENZALKONIUM CHLORIDEEver Ready First Aide013ef0a-ef3d-7af5-e053-2a95a90a54d32024-01-15WarningsExact identifier
application number: M003
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipesALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDaf850b5e-c99f-3d4e-e053-2995a90a79482024-01-10WarningsExact identifier
application number: M003
Latalia Alcohol Antiseptic 80 SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDba4b8fb3-09db-fa29-e053-2995a90a86172024-01-10WarningsExact identifier
application number: M003
Northside Hospital Amenity Kit--GI DeptALCOHOLASP Global, LLcc284eba4-0b92-4981-b3f8-d8d99b58bdfd2024-01-10WarningsExact identifier
application number: M003
Meijer 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEMeijer, Inc.33143d87-3e57-4a17-a96c-b699ad034b5b2024-01-09WarningsExact identifier
application number: M003
Meijer 70 Isopropyl Alcohol Wipes First Aid AntisepticISOPROPYL ALCOHOLMeijer, Inc2046162f-cb70-416c-ae37-14999883a8072024-01-09WarningsExact identifier
application number: M003
Lightning X AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0e6b10e7-6e84-6bfc-e063-6294a90a85372024-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE 3.0%Trifecta Pharmaceuticals USA, LLC.e4e45f11-7cd4-e693-e053-2a95a90a4c342024-01-02WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNfe5eb694-4b1b-4c47-95d5-6074155c438a2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDfe5eb694-4b1b-4c47-95d5-6074155c438a2
1038558benzalkonium chloride 0.13 % Topical ClothSYfe5eb694-4b1b-4c47-95d5-6074155c438a2
1038558benzalkonium chloride 0.13 % Topical SwabSYfe5eb694-4b1b-4c47-95d5-6074155c438a2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYfe5eb694-4b1b-4c47-95d5-6074155c438a2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYfe5eb694-4b1b-4c47-95d5-6074155c438a2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYfe5eb694-4b1b-4c47-95d5-6074155c438a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59050-264-01590500264011 PATCH in 1 POUCH (59050-264-01) / .34 g in 1 PATCH1 patch2022-03-100000-00-00NoNoCurrent