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 68 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation7560c80b-8952-4748-af3a-20e3d42556952025-09-08WarningsExact identifier
application number: M003
Green Guard Derma-Caine BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation67629392-7e02-321a-e053-2991aa0a0f242025-09-08WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb3ef1ef5-1f6f-874a-e053-2995a90a32b12025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationa0f58025-2c50-45dc-94db-cacbd4cf604c2025-09-08WarningsExact identifier
application number: M003
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
application number: M003
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationb4627f3f-6282-51bf-e053-2a95a90a3d592025-09-08WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb463d09c-4b33-3774-e053-2a95a90a046b2025-09-08WarningsExact identifier
application number: M003
Thompson Burn Cream with LidocainBENZALKONIUM CHLORIDE, LIDOCAINEThompson Safety11729e6b-b911-5c1f-e063-6394a90a0c342025-09-08WarningsExact identifier
application number: M003
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2869cb20-9cd4-54f5-e063-6294a90a5fea2025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.28694168-3362-de4f-e063-6394a90a2e352025-09-05WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e0a5382-7b58-fd6e-e063-6394a90abf662025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e09c0aa-0241-0816-e063-6294a90a481e2025-09-05WarningsExact identifier
application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3080d8a2-a780-e79b-e063-6294a90ac6542025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3081e1b5-66b4-77a8-e063-6394a90a8dd32025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30847dd5-e378-1a35-e063-6294a90a43da2025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3084d980-29ca-91ca-e063-6294a90a6c672025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3099e6af-8072-d26b-e063-6394a90a39ef2025-09-05WarningsExact 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