FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
73598-1004
11-digit product format
735981004
Labeler code
73598
Product ID
73598-1004_1b96edfa-c13e-41e7-a0a4-bdfcdccd6bc3
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
JHK Inc dba American Safety & First Aid
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-02-02
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/.5g; mg/.5g; [iU]/.5g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct73598-1004IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73598-100473598-1004-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
TRIPLE ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/.5g
NEOMYCIN SULFATE3.5 mg/.5g
POLYMYXIN B SULFATE5000 [iU]/.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26e66025-9457-42b3-9319-51302c17506eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-1004-12024-04-26C16284748780-11030e365-4afe-111a-e063-dadaa90a10e2TRIPLE ANTIBIOTIC
73598-1004-12024-01-30C16284748780-11030e365-4afe-111a-e063-dadaa90a10e2TRIPLE ANTIBIOTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1004-1TRIPLE ANTIBIOTIC25 in 1 BOXOINTMENT252
73598-1004-1TRIPLE ANTIBIOTIC0.5 g in 1 POUCHOINTMENT0.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1004TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240427_26e66025-9457-42b3-9319-51302c17506e.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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN26e66025-9457-42b3-9319-51302c17506e2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD26e66025-9457-42b3-9319-51302c17506e2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY26e66025-9457-42b3-9319-51302c17506e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73598-1004-17359810040125 POUCH in 1 BOX (73598-1004-1) / .5 g in 1 POUCH25 pouch2000-02-020000-00-00NoNoCurrent