FDA.reportPublic FDA data

Benzalkonium Chloride

Product NDC
82355-550
11-digit product format
823550550
Labeler code
82355
Product ID
82355-550_48751555-8dc5-33e6-e063-6394a90aec65
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Hand Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
ALO NEW YORK LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-21
Substance
BENZALKONIUM CHLORIDE
Active strength
.0013 mg/100mg
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
Benzalkonium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.0013 mg/100mg

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
d3afde78-b9f6-3648-e053-2a95a90a4024Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82355-550-01Benzalkonium Chloride1 mg in 1 PACKAGECLOTH16
82355-550-01Benzalkonium Chloride20 in 1 PACKAGECLOTH206
82355-550-02Benzalkonium Chloride1 mg in 1 PACKAGECLOTH16
82355-550-02Benzalkonium Chloride20 in 1 PACKAGECLOTH206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82355-550BENZALKONIUM CHLORIDE (SANITIZING HAND WIPES) CLOTH [ALO NEW YORK LLC]4Current NDC, Legacy NDC, 4 package rows20241218_d3afde78-b9f6-3648-e053-2a95a90a4024.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 66 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6ec04a-902f-2abc-e063-6394a90a96872025-09-10WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Jurassic WorldALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6f1449-8d21-8953-e063-6394a90a93ac2025-09-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6f0540-5882-2692-e063-6294a90a2f472025-09-10WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Dragon FruitETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7d57b2-04ab-2ffe-e063-6394a90af8322025-09-10WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Jasmine ShadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7df19c-00aa-5f1d-e063-6294a90af15e2025-09-10WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Mango PapayaETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7e9c95-791c-7b2e-e063-6294a90ac3652025-09-10WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUnifirst First Aid Corporation5c303611-f2d6-417b-b269-bb0013398efb2025-09-09WarningsExact identifier
application number: M003
Medi-First Plus Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation57ea7f8a-26e2-367e-e053-2a91aa0a93e12025-09-09WarningsExact identifier
application number: M003
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationf2b7e1c4-6369-9efa-e053-2a95a90a82122025-09-09WarningsExact identifier
application number: M003
McKesson Antiseptic Hand SanitizerETHYL ALCOHOLMcKesson Medical-Surgicalcc95bae9-d8ef-41f8-e053-2995a90aadab2025-09-09WarningsExact identifier
application number: M003
ECOLAB Hand SanitizerETHYL ALCOHOL 66.5%ECOLAB Food Safety Specialties, Inc.4c430aff-7f88-5529-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
application number: M003
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6ad099-c770-064f-e063-6294a90a222d2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef24-f162-5549-e063-6294a90a30b82025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef38-215c-defa-e063-6394a90a46a62025-09-09WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e44c28e-c6ed-52b4-e063-6394a90a9dd02025-09-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 % Topical ClothSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 % Topical SwabSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYd3afde78-b9f6-3648-e053-2a95a90a40246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82355-550-018235505500120 PACKAGE in 1 PACKAGE (82355-550-01) / 1 mg in 1 PACKAGE20 package2021-12-210000-00-00NoNoCurrent
82355-550-028235505500220 PACKAGE in 1 PACKAGE (82355-550-02) / 1 mg in 1 PACKAGE20 package2021-12-210000-00-00NoNoCurrent