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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsExact identifier
application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEFPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEA-S Medication Solutions01131ba6-6d5b-4710-bec3-ba1769c08c792024-10-22WarningsExact identifier
application number: M004
BACITRACINBACITRACINCVS Pharmacy15ea4415-943a-4d0a-ac23-5f37cd2cf2062024-10-22WarningsExact identifier
application number: M004
Tetracyte First Aid and Antibiotic TopicalTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INCdcb3d96a-41a5-40d8-a47e-56d419bbe6e22024-10-21WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BCVS Pharmacy3ba24e32-7078-45fb-85d1-2ab252fa9cb52024-10-16WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Inc43486da5-6e8b-45c0-bd7e-cc2d8b28c5102024-10-16WarningsExact identifier
application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin ZincBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production (Xiamen) Co., Ltd.af08c1fe-fb1a-56d2-e053-2a95a90a67c42024-10-15WarningsExact identifier
application number: M004
Exchange Select First Aid Triple Anitbiotic Pain RelievingBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLArmy & Air Force Exchange Service1c7f1700-69c0-4a71-8bb0-a71e3082efeb2024-10-14WarningsExact identifier
application number: M004
antibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E B55fa94cb-7e1c-41bc-879a-5618a828f14a2024-10-14WarningsExact identifier
application number: M004
first aid antibiotic and pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer, Inc.f0892a30-8a88-44e8-ab04-0e87c12f9c442024-10-14WarningsExact identifier
application number: M004
triple antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Incd97a69e8-4058-4c77-b628-ad3e2b97a6202024-10-14WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyb541f1a9-7e40-4c35-840f-ea1e357b580e2024-10-14WarningsExact identifier
application number: M004
Exchange Select triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BArmy & Air Force Exchange Serviceb7bf899c-44e5-48d6-bf8e-d843fd4424322024-10-12WarningsExact identifier
application number: M004
topcare triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BTopco Associates LLC675665ee-bd0d-4168-81b8-341b1258c1022024-10-12WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Changjian Medical Products Co., Ltd.34e8776c-1f36-4e1b-9d71-727591ac904d2024-10-11WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BH E B58a4d263-e234-43cd-a3bd-b19a492174d92024-10-11WarningsExact identifier
application number: M004
topcare triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC5e0fc39b-e6d4-4543-8afc-2881e2f85f9b2024-10-06WarningsExact identifier
application number: M004
Good Sense Triple Antibiotic and Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companyc3e9215f-fcef-4938-8208-df40996522892024-10-06WarningsExact identifier
application number: M004
triple antibiotic plus maximum strengthBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E Bc428b0a3-e80a-493c-ac67-807ebca3ce012024-10-06WarningsExact identifier
application number: M004
Basic Care First Aid AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmazon.com Services LLCa9247f69-0366-42dd-ae0d-39a2a6976cdc2024-10-06WarningsExact 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