FDA.reportPublic FDA data

doubleantibioticointment

Product NDC
69396-029
11-digit product format
693960029
Labeler code
69396
Product ID
69396-029_4c357686-9a96-0131-e063-6294a90abdf1
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-04
Substance
POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
10000; 500 [USP'U]/g; [USP'U]/g
Pharmacologic classes
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

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
doubleantibioticointment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/g
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19371312D4Internal UNII lookup
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308512Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4eb5202e-8e5b-6d31-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-029-22doubleantibioticointment28 g in 1 TUBEOINTMENT287
69396-029-22doubleantibioticointment2 in 1 BOXOINTMENT27
69396-029-30doubleantibioticointment1 in 1 BOXOINTMENT17
69396-029-30doubleantibioticointment28 g in 1 TUBEOINTMENT287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-029-30GM - Gram69396-029a03f5768-570f-4af3-a8d2-84c164f8ef4612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-029DOUBLEANTIBIOTICOINTMENT (BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]5Current NDC, Legacy NDC, 4 package rows20241215_4eb5202e-8e5b-6d31-e054-00144ff88e88.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 11 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntibioticBACITRACIN ZINCTARGET Corporation4d8e7146-9215-417e-93be-af706502cfee2025-07-07WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEGENOMMA LAB USA, INC.506fcda5-df44-49c8-8dbd-cab7434b06b22025-07-02WarningsExact identifier
application number: M004
DG Poly Antibiotic First Aid AntibioticBACITRACIN AND POLYMYXIN B SULFATEDollar General4d710928-5a7d-4f1a-aea0-be7fe599ae0c2025-07-02WarningsExact identifier
application number: M004
Curad Maximum Strength Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEMedline Industries, LP99e9c394-ebf1-7a27-e053-2a95a90ab1572025-07-01WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.7e8af528-eb25-4f93-9b35-8fff635932cc2025-07-01WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain Relief Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium, LLC55ef2205-aaf1-4aa4-917f-2b4cfa43b77e2025-07-01WarningsExact identifier
application number: M004
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsExact identifier
application number: M004
Meret Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.385d8642-9eae-a750-e063-6394a90a79312025-06-24WarningsExact identifier
application number: M004
ProCure Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETwin Med LLC37a3916f-cc1a-41a0-e063-6394a90a35ed2025-06-16WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICDynarex Corporation82cf8dd0-eef6-5871-e053-2991aa0a38cf2025-06-16WarningsExact identifier
application number: M004
Sion Biotext Bacitracin ZincBACITRACIN ZINCSion Biotext Medical Ltd35056345-f325-99e8-e063-6294a90a2d7e2025-06-12WarningsExact identifier
application number: M004
ProCure Bacitracin ZincBACITRACIN ZINCTwin Med LLC36da7993-7c65-7430-e063-6294a90a06262025-06-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN BJ&A Digital Inc.9b8f2046-5886-440d-a7fc-a71138d7f34b2025-06-02WarningsExact identifier
application number: M004
Lights Povidone Iodine ScrubPOVIDONE-IODINELights Medical Manufacture Co., Ltd.5e1eef53-c2c7-477e-9ee4-19c01c1881e52025-05-20WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCTrifecta Pharmaceuticals USA, LLC.4a9fe0fa-5549-4e06-e054-00144ff8d46c2025-05-15WarningsExact identifier
application number: M004
SionBiotext Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESion Biotext Medical Ltd35083d42-5823-eeb1-e063-6294a90acafa2025-05-13WarningsExact identifier
application number: M004
Multi ActionBACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb98082f3-be95-49fb-e053-2a95a90a37b82025-05-13WarningsExact identifier
application number: M004
Leader Triple antibiotic and pain reliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINECardinal Health 110 dba LEADERf4c521d9-dd05-1c23-e053-2995a90a6e2c2025-05-13WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA34f1db74-6506-d53d-e063-6394a90ac4002025-05-12WarningsExact identifier
application number: M004
Triple Antibiotic plus LidocaineBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINETRIFECTA PHARMACEUTICALS USA LLC14fda967-54ba-c964-e063-6294a90a21ee2025-04-24WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN4eb5202e-8e5b-6d31-e054-00144ff88e887
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD4eb5202e-8e5b-6d31-e054-00144ff88e887
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY4eb5202e-8e5b-6d31-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-029-22693960029222 TUBE in 1 BOX (69396-029-22) / 28 g in 1 TUBE2 tube2026-03-04NoNoCurrent
69396-029-30693960029301 TUBE in 1 BOX (69396-029-30) / 28 g in 1 TUBE1 tube2017-05-040000-00-00NoNoCurrent