Benzalkonium Chloride

Product NDC
82355-552
11-digit product format
823550552
Labeler code
82355
Product ID
82355-552_487512c1-3739-28ab-e063-6394a90a3920
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Hand Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
ALO NEW YORK LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-04
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e1f57c4-8b46-b8cc-e063-6294a90a0ebbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82355-552-01Benzalkonium Chloride20 in 1 PACKAGECLOTH204
82355-552-01Benzalkonium Chloride1 mg in 1 PACKAGECLOTH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82355-552BENZALKONIUM CHLORIDE (SANITIZING HAND WIPES) CLOTH [ALO NEW YORK LLC]2Current NDC, 2 package rows20241208_0e1f57c4-8b46-b8cc-e063-6294a90a0ebb.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 20 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Triple AntibioticFIRST AID TRIPLE ANTIBIOTICCardinal Health 110,Inc.844cd9a1-b68e-47d8-a5eb-c9e880ba019e2024-01-18WarningsExact identifier
application number: M004
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact identifier
application number: M004
Leader Poly BacitracinFIRST AID ANTIBIOTICCardinal Health 110, Inc.442e11aa-7d14-44f9-bf14-446018f1de0d2024-01-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation7b16cb9b-5847-4360-9974-2118f4a2c70f2024-01-17WarningsExact identifier
application number: M004
Green Guard Triple AntibioticBACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd456e2f-e6d7-d2ad-e053-2995a90a5c122024-01-17WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd432abc-fefb-1b4b-e053-2995a90acb182024-01-17WarningsExact identifier
application number: M004
Crane Safety Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECrane Safety LLC96dbc282-4b3f-aaf3-e053-2995a90a56942024-01-17WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETarget Corporation10c4a1b5-bb91-48da-b0ae-303e4adf793a2024-01-17WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCTarget Corporation6020956d-2f58-4be8-97da-3f6b7e0f34aa2024-01-17WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefTRIPLE ANTIBIOTICTarget Corporation8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb2024-01-17WarningsExact identifier
application number: M004
Travel Savvy First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBellegrove Medical Supply, Inc.69fa1c9d-5e6d-4593-e053-2a91aa0a76902024-01-16WarningsExact identifier
application number: M004
American Safety First Aid AntispeticISOPROPYL ALCOHOLOrazen Incea302ba4-a63d-e713-e053-2995a90a3fc42024-01-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESled Distribution, LLCe7398df8-8e23-5439-e053-2a95a90ac3aa2024-01-15WarningsExact identifier
application number: M004
ER Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AID20f97e1c-584f-4844-afd8-8641ffe2f4662024-01-11WarningsExact identifier
application number: M004
Lightning X Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0e66af91-e0b4-827f-e063-6294a90a98472024-01-07WarningsExact identifier
application number: M004
triple antibiotic 01BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECosmuses Cosmetics (Ningbo) Co., Ltd.0e1b23f3-fa1e-f42b-e063-6394a90a3bec2024-01-04WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTICLil' Drug Store products, Inc.0d98477b-aa33-ebb7-e063-6294a90a597f2024-01-03WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCd9f2702c-a514-cb69-e053-2a95a90a29a92024-01-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Geri-Care Pharmaceuticals, Corpef309620-1cf9-d007-e053-2995a90ad46f2024-01-02WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCGeri-Care Pharmaceuticals, Corp.eec90f72-fd13-05c9-e053-2995a90a642a2024-01-02WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82355-552-018235505520120 PACKAGE in 1 PACKAGE (82355-552-01) / 1 mg in 1 PACKAGE20 package2024-01-04NoNoCurrent