FDA.reportPublic FDA data

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 19 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic First Aid AntibioticBACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATEUniversal Distribution Center LLC78f00296-267b-44c3-a9e3-c40f122e905e2024-05-14WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEJHK Inc dba American Safety & First Aid26e66025-9457-42b3-9319-51302c17506e2024-04-26WarningsExact identifier
application number: M004
Hydrogen PeroxideHYDROGEN PEROXIDEJHK Inc1472c854-09c8-4ad8-b8a6-0235440ac26b2024-04-26WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
application number: M004
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEM-star (Hubei) Health&Care Products Co., Ltd.c6f2656e-b822-4d61-b557-dd2046dd51f52024-04-01WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATECVS PHARMACY, INC32e92acf-2e48-4933-8e08-e1df650e7d192024-03-15WarningsExact identifier
application number: M004
Major BacitracinBACITRACINMajor Pharmaceuticals13288efb-e282-68f8-e063-6294a90ae7122024-03-08WarningsExact identifier
application number: M004
UniShield TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnishield00b85d3a-322b-43c1-b022-5f6ed50c66092024-03-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.1277942d-753f-ab69-e063-6394a90a496a2024-02-28WarningsExact identifier
application number: M004
Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDESafetec of America, Inc.ca1df4a0-844d-4b1d-b972-f2704a8ebbab2024-02-16WarningsExact identifier
application number: M004
Single AntibioticBACITRACIN ZINCSafetec of America, Inc.9993c204-6e61-4da3-90ef-2b7dfa09c9202024-02-14WarningsExact identifier
application number: M004
Single Antibiotic with NeomycinNEOMYCIN SULFATESafetec of Americae989cf7e-f3d1-42d2-af45-fc80095b97cb2024-02-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.96c41fc1-81f9-4757-abc6-867b5383ed5d2024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.2c2aa8af-2adb-4f59-ac20-15818d0e28e72024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.03c05028-5a5f-4690-a836-cc1b1044ab392024-02-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.59494d5c-dd8a-431c-8e6a-4e1151ba74602024-02-05WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTICBluePoint Laboratoriesc47e15bd-1062-4cca-e053-2995a90a90752024-01-31WarningsExact identifier
application number: M004
NeomycinNEOMYCIN OINTMENTDynarex Corporation0f9e087b-6e86-a3c7-e063-6394a90ac8d42024-01-23WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact 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