FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
54473-291
11-digit product format
544730291
Labeler code
54473
Product ID
54473-291_4747f7af-efc5-1b57-e063-6294a90adb8c
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc and Neomycin and Polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-07-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
500; 3.5; 10000 U/g; mg/g; U/g
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

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 ZINC500 U/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 U/g

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
1359363Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65ae4607-689d-6056-e053-2a91aa0aff56Available 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
54473-291-012020-03-19C16284748780-19d75b9d0-69a6-f424-e053-dadaa90a57ceTriple Antibiotic Ointment
54473-291-012020-01-31C16284748780-19d75b9d0-69a6-f424-e053-dadaa90a57ceTriple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-291-01Triple Antibiotic14 g in 1 TUBEOINTMENT145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-291TRIPLE ANTIBIOTIC (BACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [MELALEUCA, INC.]4Current NDC, Legacy NDC, 1 package rows20240919_65ae4607-689d-6056-e053-2a91aa0aff56.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 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
1359363bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentPSN65ae4607-689d-6056-e053-2a91aa0aff565
1359363bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Topical OintmentSCD65ae4607-689d-6056-e053-2a91aa0aff565
1359363bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentSY65ae4607-689d-6056-e053-2a91aa0aff565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-291-015447302910114 g in 1 TUBE (54473-291-01) 14 g2018-01-010000-00-00NoNoCurrent