FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
69103-5603
11-digit product format
691035603
Labeler code
69103
Product ID
69103-5603_1f4591c0-4b50-0625-e063-6394a90afa68
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Provision Medical
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-25
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct69103-5603IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69103-560369103-5603-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 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
bbf4b99c-9738-4855-82a6-f4e213924ec9Available 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
69103-5603-12024-03-20C16284748780-11030e365-5fc8-111a-e063-dadaa90a10e269103-5603. Triple Antibiotic
69103-5603-12024-01-30C16284748780-11030e365-5fc8-111a-e063-dadaa90a10e269103-5603. Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69103-5603-1Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-5603TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PROVISION MEDICAL]5Current NDC, Legacy NDC, 1 package rows20240810_bbf4b99c-9738-4855-82a6-f4e213924ec9.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
application number: M004
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
application number: M004
Premier Value Bacitracin ZincBACITRACIN ZINCPharmacy Value Alliance LLC99d789be-aa85-0917-e053-2a95a90acd132024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
application number: M004
Family Wellness First Aid AntibioticFAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA, LLC9157681a-3ed1-096e-e053-2a95a90a05e32024-12-18WarningsExact identifier
application number: M004
Family Wellness OriginalFAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN BTrifecta Pharmaceuticals USA LLC.915759af-0d4f-6a87-e053-2a95a90acbd62024-12-18WarningsExact identifier
application number: M004
Family Wellness Pain Scar ItchBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLTrifecta Pharmaceutical USA LLC9e507ec5-310d-3a21-e053-2a95a90a15a62024-12-18WarningsExact identifier
application number: M004

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 OintmentPSNbbf4b99c-9738-4855-82a6-f4e213924ec95
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDbbf4b99c-9738-4855-82a6-f4e213924ec95
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYbbf4b99c-9738-4855-82a6-f4e213924ec95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69103-5603-169103560301.5 g in 1 POUCH (69103-5603-1) 2022-07-250000-00-00NoNoCurrent