FDA.reportPublic FDA data

TRIBIOTIC

Product NDC
50332-0032
11-digit product format
503320032
Labeler code
50332
Product ID
50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
HART Health
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-10-03
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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
TRIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

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

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0032-12022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-22022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-32022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-42022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-52022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-62022-11-28C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-12021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-22021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-32021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-42021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-52021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC
50332-0032-62021-01-29C16284748780-1ba0f9c33-15f6-a910-e053-dadaa90a0b85TRIBIOTIC

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0032TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]5Current NDC, Legacy NDC20240119_d8f175f9-f526-4c73-a171-49309ca16cb0.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 OintmentPSNd8f175f9-f526-4c73-a171-49309ca16cb05
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDd8f175f9-f526-4c73-a171-49309ca16cb05
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYd8f175f9-f526-4c73-a171-49309ca16cb05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50332-0032-15033200320110 PACKET in 1 BOX, UNIT-DOSE (50332-0032-1) / .9 g in 1 PACKET10 packet2005-10-030000-00-00NoNoCurrent
50332-0032-25033200320225 PACKET in 1 BOX, UNIT-DOSE (50332-0032-2) / .9 g in 1 PACKET25 packet2005-10-030000-00-00NoNoCurrent
50332-0032-35033200320325 PACKET in 1 BOX, UNIT-DOSE (50332-0032-3) / .5 g in 1 PACKET25 packet2005-10-030000-00-00NoNoCurrent
50332-0032-450332003204144 PACKET in 1 BOX, UNIT-DOSE (50332-0032-4) / .9 g in 1 PACKET144 packet2005-10-030000-00-00NoNoCurrent
50332-0032-550332003205144 PACKET in 1 BOX, UNIT-DOSE (50332-0032-5) / .5 g in 1 PACKET144 packet2005-10-030000-00-00NoNoCurrent
50332-0032-65033200320610 PACKET in 1 BOX, UNIT-DOSE (50332-0032-6) / .5 g in 1 PACKET10 packet2005-10-030000-00-00NoNoCurrent