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

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 Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui1359363

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

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