FDA.reportPublic FDA data

Antiseptic

Product NDC
73598-0681
Requested package NDC
73598-0681-1
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
2026-12-31
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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic
Listing expiration
2026-12-31

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 1 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESalado Sales, Inc52e275d3-88c9-47f1-8dcf-68445c7be4a72026-08-05WarningsExact identifier
application number: M004
Wound Wash Antiseptic Saline with Benzalkonium ChlorideWOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDENeilMed Pharmaceuticals, Inc.55a1fc63-2527-4033-e054-00144ff8d46c2026-08-05WarningsExact identifier
application number: M004
ProcureTriple Antibiotic Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BTWIN MED, LLC71592776-407b-489c-8cdb-8c0573d844f82026-08-03WarningsExact identifier
application number: M004
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2026-08-03WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC236c62bf-3de0-0b3e-e063-6394a90ad6c62026-07-21WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC21b38b00-1e64-83d8-e063-6294a90a07bd2026-07-21WarningsExact identifier
application number: M004
DERMFREE Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a5a5603-3478-5f7a-e063-6294a90acc402026-07-21WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Inc560ba2ca-ad0f-9202-e063-6294a90aaefd2026-07-14WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc561bf89c-ca78-d7e4-e063-6394a90a983f2026-07-14WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc561c1e51-19f4-90ce-e063-6294a90a5f9b2026-07-08WarningsExact identifier
application number: M004
Ever Ready First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AIDee1ad6d7-e9c1-2b20-e053-2995a90a33662026-07-03WarningsExact identifier
application number: M004
Single Antibiotic with bacitracinBACITRACIN ZINCSafetec of America4ae9a105-e3f9-4015-8844-085e0b34cdb62026-06-25WarningsExact identifier
application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact identifier
application number: M004
Medi First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation545fa5b6-781c-18ae-e063-6294a90a2f0d2026-06-16WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTIC ORIGINAL STRENGTHAldermed Inc.19eace87-b505-4be6-93b3-db5323e342162026-06-12WarningsExact identifier
application number: M004
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICAldermed Inc.7f4bff4f-588d-4e45-8aa3-f95b4d746f252026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLAldermed Inc.5bfc7776-1030-48ba-9df4-897c4984c9e62026-06-08WarningsExact 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