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
2026-12-31
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 3 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation545fa5b6-781c-18ae-e063-6294a90a2f0d2026-06-16WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTIC ORIGINAL STRENGTHAldermed Inc.19eace87-b505-4be6-93b3-db5323e342162026-06-12WarningsExact identifier
application number: M004
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICAldermed Inc.7f4bff4f-588d-4e45-8aa3-f95b4d746f252026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLAldermed Inc.5bfc7776-1030-48ba-9df4-897c4984c9e62026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4545c043-8e8e-4288-b4d8-e6ec9d72f9792026-06-04WarningsExact identifier
application number: M004
First Aid Kit, Orazen Inc5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSOrazen Inc525bcb89-af5b-8652-e063-6294a90a41a62026-06-03WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.d77239e6-5e81-439a-b0cd-f8be591694422026-06-02WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BHyVee Inc3ac9f0fc-e08c-49d9-9079-3ba0393c612b2026-06-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLHyVee Inc69a4b642-b7ec-43cc-aa57-6858da0b3d632026-06-02WarningsExact identifier
application number: M004
Careland Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPlanet (Anhui) Pharmaceutical Co., Ltd.0e64179d-fce2-48fc-833e-ce43a54b987c2026-05-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Fanjian Medical Product Co.,Ltdf44ab989-c618-1831-e053-2995a90adc8e2026-05-28WarningsExact identifier
application number: M004
Vitastem-tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.7ffe82a4-864b-48c7-9307-d262f20ca01e2026-05-26WarningsExact identifier
application number: M004
Viaderma Vitastem First Aid Topical AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC6eb04a76-7995-4df6-9c9b-dd450537e5382026-05-26WarningsExact identifier
application number: M004
Medi-First Bacitracin ZincBACITRACINUnifirst First Aid Corporation54609a4f-0fe9-b750-e063-6394a90ae9ce2026-05-26WarningsExact identifier
application number: M004
Hand SanALCOHOLRochester Midland Corporation2d89982d-d1fd-4a98-8b44-c2ae3545be582026-05-14WarningsExact identifier
application number: M004
first aid antibioticBACITRACINHyVee Inc97c87111-260a-48d0-92cd-e22f55a48c7d2026-05-12WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.32df5cca-77bc-45d2-b1f6-2cfdfc371ea92026-05-12WarningsExact identifier
application number: M004
ANTIBIOTIC Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.653c88bf-5b7d-45be-a131-d59990573e9c2026-05-12WarningsExact identifier
application number: M004
Fresh StartCHLOROXYLENOLPro Chem, Inc.dd1708d8-0bb2-c96a-e053-2995a90a5b862026-05-11WarningsExact 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