FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
11673-892
11-digit product format
116730892
Labeler code
11673
Product ID
11673-892_383955f7-4534-4f5a-ae1e-f889e95737ac
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Target Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-31
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE
Active strength
400; 5000; 3.5 [USP'U]/g; [USP'U]/g; mg/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

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 [USP'U]/g
POLYMYXIN B SULFATE5000 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup
057Y626693Internal 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
10c4a1b5-bb91-48da-b0ae-303e4adf793aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-892-56Triple Antibiotic28 g in 1 TUBEOINTMENT282
11673-892-56Triple Antibiotic2 in 1 CARTONOINTMENT22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-892TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [TARGET CORPORATION]2Current NDC, 2 package rows20240131_10c4a1b5-bb91-48da-b0ae-303e4adf793a.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 9 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd265f094-e654-4c68-9215-b5d061af885d2025-09-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd7c1a10e-c38d-4ae8-9a27-c07c2208ca842025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEThompsonf883c4cb-c32c-76e3-e053-6294a90aa4fc2025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEThompsonde9489de-e677-2bd3-e053-2a95a90acfb42025-09-08WarningsExact identifier
application number: M004
BACITRACIN ZINCFIRST AID ANTIBIOTICEncube Ethicals, Inc.613cbed4-9790-4e6b-a61b-b7b7a8ee59c92025-09-04WarningsExact identifier
application number: M004
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact 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 OintmentPSN10c4a1b5-bb91-48da-b0ae-303e4adf793a2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD10c4a1b5-bb91-48da-b0ae-303e4adf793a2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY10c4a1b5-bb91-48da-b0ae-303e4adf793a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-892-56116730892562 TUBE in 1 CARTON (11673-892-56) / 28 g in 1 TUBE2 tube2024-01-31NoNoCurrent