FDA.reportPublic FDA data

Antiseptic

Product NDC
73598-0681
11-digit product format
735980681
Labeler code
73598
Product ID
73598-0681_a41dcb58-7a0a-45b4-9cd3-37ecf8906b38
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
JHK Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-14
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
100; 50 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73598-0681-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage73598-0681-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage73598-0681-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage73598-0681-1bd6a592717d7…303034d00443…

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
Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE100 mg/mL
BENZOCAINE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ac5d890-c262-4a30-9fd8-2de6cb0f7601Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-0681-12024-05-07C16284748780-1d6a99b39-d443-a426-e053-dadaa90af4c20ac5d890-c262-4a30-9fd8-2de6cb0f7601
73598-0681-12022-01-28C16284748780-1d6a99b39-d443-a426-e053-dadaa90af4c20ac5d890-c262-4a30-9fd8-2de6cb0f7601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-0681-1Antiseptic59.1 mL in 1 BOTTLE, SPRAYSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-0681ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [JHK INC]2Current NDC, Legacy NDC, 1 package rows20240509_0ac5d890-c262-4a30-9fd8-2de6cb0f7601.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 11 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntibioticBACITRACIN ZINCTARGET Corporation4d8e7146-9215-417e-93be-af706502cfee2025-07-07WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEGENOMMA LAB USA, INC.506fcda5-df44-49c8-8dbd-cab7434b06b22025-07-02WarningsExact identifier
application number: M004
DG Poly Antibiotic First Aid AntibioticBACITRACIN AND POLYMYXIN B SULFATEDollar General4d710928-5a7d-4f1a-aea0-be7fe599ae0c2025-07-02WarningsExact identifier
application number: M004
Curad Maximum Strength Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEMedline Industries, LP99e9c394-ebf1-7a27-e053-2a95a90ab1572025-07-01WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.7e8af528-eb25-4f93-9b35-8fff635932cc2025-07-01WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain Relief Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium, LLC55ef2205-aaf1-4aa4-917f-2b4cfa43b77e2025-07-01WarningsExact identifier
application number: M004
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsExact identifier
application number: M004
Meret Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.385d8642-9eae-a750-e063-6394a90a79312025-06-24WarningsExact identifier
application number: M004
ProCure Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETwin Med LLC37a3916f-cc1a-41a0-e063-6394a90a35ed2025-06-16WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICDynarex Corporation82cf8dd0-eef6-5871-e053-2991aa0a38cf2025-06-16WarningsExact identifier
application number: M004
Sion Biotext Bacitracin ZincBACITRACIN ZINCSion Biotext Medical Ltd35056345-f325-99e8-e063-6294a90a2d7e2025-06-12WarningsExact identifier
application number: M004
ProCure Bacitracin ZincBACITRACIN ZINCTwin Med LLC36da7993-7c65-7430-e063-6294a90a06262025-06-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN BJ&A Digital Inc.9b8f2046-5886-440d-a7fc-a71138d7f34b2025-06-02WarningsExact identifier
application number: M004
Lights Povidone Iodine ScrubPOVIDONE-IODINELights Medical Manufacture Co., Ltd.5e1eef53-c2c7-477e-9ee4-19c01c1881e52025-05-20WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCTrifecta Pharmaceuticals USA, LLC.4a9fe0fa-5549-4e06-e054-00144ff8d46c2025-05-15WarningsExact identifier
application number: M004
SionBiotext Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESion Biotext Medical Ltd35083d42-5823-eeb1-e063-6294a90acafa2025-05-13WarningsExact identifier
application number: M004
Multi ActionBACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb98082f3-be95-49fb-e053-2a95a90a37b82025-05-13WarningsExact identifier
application number: M004
Leader Triple antibiotic and pain reliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINECardinal Health 110 dba LEADERf4c521d9-dd05-1c23-e053-2995a90a6e2c2025-05-13WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA34f1db74-6506-d53d-e063-6394a90ac4002025-05-12WarningsExact identifier
application number: M004
Triple Antibiotic plus LidocaineBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINETRIFECTA PHARMACEUTICALS USA LLC14fda967-54ba-c964-e063-6294a90a21ee2025-04-24WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73598-0681-17359806810159.1 mL in 1 BOTTLE, SPRAY (73598-0681-1) 59.1 ml2020-02-140000-00-00NoNoCurrent