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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLKroger Companye31c8d92-bf9f-4b7f-8f81-54199745cd202024-10-06WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmerican Sales Company9df0c4c2-f045-4f25-878e-4d55a99b8df42024-10-06WarningsExact identifier
application number: M004
DG Health AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC0a04da51-d169-4eff-b70c-352913ce39662024-10-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway8d5bac6b-98b6-4fc4-983a-ca5292b4c3612024-10-06WarningsExact identifier
application number: M004
antibiotic plus pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEKroger Company91828614-d0d1-472f-802f-43f4738601252024-09-26WarningsExact identifier
application number: M004
DG Health AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp Incefaf3ea5-0a2f-414f-96eb-7e8cfba9e9012024-09-26WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutions29c223ff-3cb7-4578-a326-08516e89cd472024-09-26WarningsExact identifier
application number: M004
Signature Care First Aid AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway78ecfb28-f4c4-4f70-90c9-d6d7bf920fb52024-09-26WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmerisource Bergen3d1694ea-3f3e-45d5-8edf-8b31ac7d3a402024-09-26WarningsExact identifier
application number: M004
Rexall AntibioticBACITRACINDolgencorp, LLC7ad42602-6e42-47c8-91a8-e4785fa8d24b2024-09-23WarningsExact identifier
application number: M004
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsExact identifier
application number: M004
signature care first aid antibioticBACITRACINSafeway38fc0c5c-e0bc-44d2-acbd-d4d329fef1e12024-09-23WarningsExact identifier
application number: M004
AntibioticBACITRACINTopco Associates LLC3267a695-9e53-42f2-b30a-022653a0b8bb2024-09-23WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger Company4490cece-0635-4ea7-91ab-324a971fef632024-09-23WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPadagis Israel Pharmaceuticals Ltd28fff253-ddd4-4669-aa90-b4caf48c905f2024-09-22WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSafeway044aff98-f398-40f5-8c18-2751b4ab43842024-09-18WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAmerican Sales Company09a0b0b9-1806-4ff9-80fa-448dabbf2cc72024-09-18WarningsExact identifier
application number: M004
equaline first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BUnited Natural Foods, Inc. dba UNFI022e009e-0192-4089-86f3-4d63448e0f882024-09-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BKroger Companyc531bac4-ab15-4fde-99a7-19e20ce103872024-09-17WarningsExact identifier
application number: M004
basic care first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BAmazon.com Services LLCc159b18d-0d6e-409f-8b2b-e8f28cd856332024-09-17WarningsExact 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