FDA.reportPublic FDA data

triple antibiotic

Product NDC
41250-433
11-digit product format
412500433
Labeler code
41250
Product ID
41250-433_6839f211-f184-4ae6-8dfe-c7eb21d79b00
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-03
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [USP'U]/g; mg/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 ZINC500 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43486da5-6e8b-45c0-bd7e-cc2d8b28c510Available 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-433-58triple antibiotic14 g in 1 TUBEOINTMENT144
41250-433-58triple antibiotic1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-433TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]4Current NDC, Legacy NDC, 2 package rows20241102_43486da5-6e8b-45c0-bd7e-cc2d8b28c510.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 14 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Antibiotic plus Burn ReliefBACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCITrifecta Pharmaceuticals USA LLC048871e2-c917-292d-e063-6394a90af1302024-12-18WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcare0c3fc798-9a97-5316-e063-6394a90a68302024-12-18WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCRugby Laboratoriesac3c9897-c812-1360-e053-2a95a90ad5912024-12-17WarningsExact identifier
application number: M004
Major BacitracinBACITRACIN ZINCMajor Pharmaceuticalsa23ce772-7078-0a4b-e053-2995a90aff0d2024-12-17WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCeea0d90c-914b-2624-e053-2a95a90a34c92024-12-13WarningsExact identifier
application number: M004
OP First Aid Series TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.cadebf07-dd48-4855-8296-7a91e28d71232024-12-05WarningsExact identifier
application number: M004
triple antibiotic and pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyf0864d78-23e6-4e6c-bc67-7ba3e6dd862c2024-12-03WarningsExact identifier
application number: M004
triple antibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEPublix Super Markets Inc330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f92024-11-25WarningsExact identifier
application number: M004
WinCo Maximum Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDEWinCo Foods, LLC01b03c7e-6c4e-43aa-8480-aff1c2688f7f2024-11-21WarningsExact identifier
application number: M004
WinCo Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWinCo Foods, LLCe364b623-6e20-4894-8d4c-5c739be78f862024-11-21WarningsExact identifier
application number: M004
Winco Bacitracin ZincBACITRACIN ZINCWinCo Foods, LLCdcdf647f-fa32-4b72-b714-a77e8e3323582024-11-21WarningsExact identifier
application number: M004
Walgreens Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyf4feccc3-ac25-4d8a-9b68-9a24f755524a2024-11-20WarningsExact identifier
application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyfbc364d7-d8b8-43f5-99cc-290438f3982b2024-11-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf9a48f73-aa12-cf68-e053-6294a90a8e532024-11-19WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEAcme United Corporatione55cbf7e-c955-7f1a-e053-2a95a90a3f282024-11-19WarningsExact identifier
application number: M004
First Aid Only Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf4eba34c-ce31-3004-e053-2995a90a245b2024-11-19WarningsExact identifier
application number: M004
First Aid Only Neomycin AntibioticNEOMYCIN SULFATEAcme United Corporationc651e98e-aabe-de46-e053-2a95a90a63072024-11-19WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCf07d3bca-4312-46ed-b0c4-f886c01bd0952024-11-14WarningsExact identifier
application number: M004
Polysporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLCe0fcf83e-a374-4fc0-a629-8730330543922024-11-14WarningsExact identifier
application number: M004
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN43486da5-6e8b-45c0-bd7e-cc2d8b28c5104
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD43486da5-6e8b-45c0-bd7e-cc2d8b28c5104
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY43486da5-6e8b-45c0-bd7e-cc2d8b28c5104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-433-58412500433581 TUBE in 1 CARTON (41250-433-58) / 14 g in 1 TUBE1 tube2017-10-030000-00-00NoNoCurrent