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 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FifthPulse Hydrocortisone 4ozHYDROCORTISONEFront Pharmaceutical PLC39fb29c8-6a28-e87e-e063-6294a90a78da2025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEFred's, Inc.41ee7a50-d36b-4214-b6f8-44f47ab44a842025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATELidl US, LLC98389314-c2cf-4510-ab3d-41c4c47200192025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN BPublix Super Markets Inc72bdb96c-af93-4a9b-93d9-81a94b6ff7562025-07-15WarningsExact identifier
application number: M004
Live Better Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEThe Great Atlantic & Pacific Tea Company7e7a0b4c-67a9-42f3-aacd-2606fde250902025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETopco Associates LLC55a8a52c-4d03-417d-9283-406f6879bcb52025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEFRED'S, INC.a44db5d1-7a74-44aa-9aa7-6247e771aaf22025-07-15WarningsExact identifier
application number: M004
Shopko Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEShopko Stores Operating Co., LLC5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa2025-07-15WarningsExact identifier
application number: M004
sunmark triple antibiotic plus pain reliefPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC941a6a71-e898-4af3-989a-6d3aa32243382025-07-15WarningsExact identifier
application number: M004
TopCare Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC0fc0dbc6-ca1d-42be-8016-68e64f1197062025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalgreen Companye2b7fc5b-c796-4ed1-aea7-4c810df250d52025-07-15WarningsExact identifier
application number: M004
Publix antibiotic plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEPublix Super Markets Incd0193bf1-a257-490e-a058-5e6a514981da2025-07-15WarningsExact identifier
application number: M004
Live Better Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEThe Great Atlantic & Pacific Tea Company7d3435ad-7d73-4db6-8019-3040b3dadfa92025-07-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWal-Mart Stores, Inc.f5199476-1ce2-4a82-9685-40d78b7a89352025-07-14WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC38414fff-8dad-44d0-9dfa-f89a63ef9b442025-07-14WarningsExact identifier
application number: M004
sunmark double antibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEStrategic Sourcing Services LLC2868de5c-4894-45ee-9647-9acd3bde7cfc2025-07-14WarningsExact identifier
application number: M004
Live Better Bacitracin ZincBACITRACIN ZINCThe Great Atlantic & Pacific Tea Company6915940c-2eae-445c-ba58-e39d221e9d3d2025-07-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSTRATEGIC SOURCING SERVICES LLC4594948d-1f25-4d3c-a615-9e6edda05a102025-07-11WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Bacitracin ZincBACITRACIN ZINCAmerisourceBergen3fb302b5-7273-412c-a2ba-b76183e3f1792025-07-11WarningsExact identifier
application number: M004
TopCare Bacitracin ZincBACITRACIN ZINCTopco Associates LLC5b59e26d-cc25-49a6-ac8b-f79398e18f2d2025-07-07WarningsExact 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