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 90 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact 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