FDA.reportPublic FDA data

Benzalkonium Chloride

Product NDC
82355-551
11-digit product format
823550551
Labeler code
82355
Product ID
82355-551_45390be0-fcf5-3640-e063-6394a90a2697
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
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
Benzalkonium Chloride
Listing expiration
2026-12-31

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3d95355-3af7-43e3-e053-2a95a90a0fa4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82355-551-01Benzalkonium Chloride20 in 1 PACKAGECLOTH205
82355-551-01Benzalkonium Chloride1 mg in 1 PACKAGECLOTH15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82355-551BENZALKONIUM CHLORIDE (SANITIZING HAND WIPES) CLOTH [ALO NEW YORK LLC]4Current NDC, Legacy NDC, 2 package rows20241218_d3d95355-3af7-43e3-e053-2a95a90a0fa4.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 59 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CAREBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONf93c55f9-b3e1-45f6-8e0d-09e60f5b822f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - NORISC - INCONTINENT WASHBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONed26fa74-5ae8-4294-b61d-682d6ad4b32a2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSERBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONd06b0489-86d3-4bf1-928f-fc524a71560e2025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack-BASEALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc86458169-92eb-45a5-b3cc-6eccd8caa1e82025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack BASESODIUM MONOFLUOROPHOSPATEALLIANCE FORMULATIONS5d0e768f-086c-4b8c-b618-6dde70f302f92025-10-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a5db85-05b8-ecd6-e063-6394a90ac3872025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a62d9f-4d46-f8ca-e063-6294a90ae1ed2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a69d10-f7bf-cf17-e063-6294a90a177d2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a7735f-03b7-4fdc-e063-6394a90a100b2025-10-21WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Cashmere CharALCOHOLShenzhen Lantern Scicence Co.,Ltd.41938c11-391c-0a55-e063-6394a90ad4512025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tea and TimberALCOHOLShenzhen Lantern Scicence Co.,Ltd.4193d08a-bc54-ef3b-e063-6294a90a06082025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41940273-689d-0f44-e063-6294a90a957f2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Vanilla VerdantALCOHOLShenzhen Lantern Scicence Co.,Ltd.41942841-faa9-114e-e063-6294a90a0e582025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Zen and ZestALCOHOLShenzhen Lantern Scicence Co.,Ltd.419441a8-a6df-e15d-e063-6294a90a02ae2025-10-20WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETWorld Perfumes Inc419cc9a2-bfde-a516-e063-6294a90a065c2025-10-20WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82355-551-018235505510120 PACKAGE in 1 PACKAGE (82355-551-01) / 1 mg in 1 PACKAGE20 package2021-12-210000-00-00NoNoCurrent