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
2027-12-31
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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0032-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0032-6fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0032-1fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0032-5fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0032-4fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0032-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0032-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0032-686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0032-186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0032-586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0032-486f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0032-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0032-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0032-6bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0032-1bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0032-5bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0032-4bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0032-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0032-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0032-68dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0032-18dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0032-58dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0032-48dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0032-28dfbde2a14a4…c9ff85d89658…

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
TRIBIOTIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
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
d8f175f9-f526-4c73-a171-49309ca16cb0Available 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, Related label table
NDCEffectiveRelated label
50332-0032-12022-11-28TRIBIOTIC
50332-0032-22022-11-28TRIBIOTIC
50332-0032-32022-11-28TRIBIOTIC
50332-0032-42022-11-28TRIBIOTIC
50332-0032-52022-11-28TRIBIOTIC
50332-0032-62022-11-28TRIBIOTIC
50332-0032-12021-01-29TRIBIOTIC
50332-0032-22021-01-29TRIBIOTIC
50332-0032-32021-01-29TRIBIOTIC
50332-0032-42021-01-29TRIBIOTIC
50332-0032-52021-01-29TRIBIOTIC
50332-0032-62021-01-29TRIBIOTIC

DailyMed Socrata Ingredients#

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

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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
application number: M
NUTRALOXCALCIUM CARBONATEHART Health3941b84e-3b4b-46eb-851b-979bac1ae9972025-12-31WarningsExact identifier
application number: M
PVP IodinePOVIDONE-IODINEHART Health06b085dd-934d-40e9-aa0d-2dd9cdccd5352025-12-31WarningsExact identifier
application number: M
WOUND WIPESBENZALKONIUM CHLORIDEHART Health4942195e-2941-4111-8ab7-2891c316bd272025-12-31WarningsExact identifier
application number: M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
application number: M
MG FoamSanBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.c5311836-674a-400b-a0d3-92f959d926822025-12-29WarningsExact identifier
application number: M
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
application number: M
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
application number: M
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
application number: M
Adult Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.4522f745-b88d-4021-a5dc-0161f1967dc92025-12-24WarningsExact identifier
application number: M
MG DermaFoamBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.4a43a605-f333-4c76-a476-476a9cc2e13a2025-12-23WarningsExact identifier
application number: M
MG DermaGel 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.56ac723b-3ede-4c94-bf4a-0572a7b42b592025-12-23WarningsExact identifier
application number: M
MG DermaSan 72ISOPROPYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.cccdefbc-09ef-417f-9b7a-1b254ae6e4382025-12-23WarningsExact identifier
application number: M
MG FoamSan 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.11fc23dd-80e1-4df1-8c19-f759ecb34f1a2025-12-23WarningsExact identifier
application number: M
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
application number: M
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
application number: M
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
application number: M
Antibacterial Liquid HandBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.ea0a5970-e95f-4090-bbe3-7df9e04393b52025-12-23WarningsExact identifier
application number: M
MG DermaCleanN/AMorgan Gallacher Inc.ed3d983e-0a6e-4de4-832a-0020f77110112025-12-23WarningsExact identifier
application number: M
MG DermaSanN/AMorgan Gallacher Inc.d4c0de39-8570-4a05-a5e3-3752545ed95f2025-12-23WarningsExact identifier
application number: M

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