Triple Antibiotic

Product NDC
53329-087
11-digit product format
533290087
Labeler code
53329
Product ID
53329-087_40c09b61-e011-85ed-e063-6294a90a0d85
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'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 ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-087-01Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.418
53329-087-01Triple Antibiotic1 in 1 BOXOINTMENT118
53329-087-87Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.918
53329-087-96Triple Antibiotic144 in 1 BOXOINTMENT14418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-087-87EA - Each53329-087a8a17112-3be1-4a4d-a568-ed7ee069673f12018-03-08
53329-087-96EA - Each53329-08738bc23c3-cb05-4b94-a06f-1f44fbc6088112018-03-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-087TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, LP]17Current NDC, Legacy NDC, 4 package rows20241204_301ebb9a-033b-4f04-99ff-571e921924ca.zip

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 OintmentPSN301ebb9a-033b-4f04-99ff-571e921924ca18
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD301ebb9a-033b-4f04-99ff-571e921924ca18
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY301ebb9a-033b-4f04-99ff-571e921924ca18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-087-01533290087011 TUBE in 1 BOX (53329-087-01) / 28.4 g in 1 TUBE1 tube2018-01-010000-00-00NoNoCurrent
53329-087-8753329008787.9 g in 1 PACKET (53329-087-87) 2018-01-010000-00-00NoNoCurrent
53329-087-9653329008796144 PACKET in 1 BOX (53329-087-96) / .9 g in 1 PACKET (53329-087-87) 144 packet2018-01-010000-00-00NoNoCurrent