FDA.reportPublic FDA data

triple antibiotic

Product NDC
41250-679
11-digit product format
412500679
Labeler code
41250
Product ID
41250-679_cb2359ef-f85b-49ed-9376-3da78eb6c9f4
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-17
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
Brand name suffix
plus pain relief
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
d97a69e8-4058-4c77-b628-ad3e2b97a620Available 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-679-162024-01-31C16284748780-11030e365-6bc9-111a-e063-dadaa90a10e2Meijer Distribution, Inc. Triple Antibiotic + Pain Relief Ointment Drug Facts
41250-679-582024-01-31C16284748780-11030e365-6bc9-111a-e063-dadaa90a10e2Meijer Distribution, Inc. Triple Antibiotic + Pain Relief Ointment Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-679-16triple antibioticplus pain relief2 in 1 CARTONOINTMENT26
41250-679-58triple antibioticplus pain relief14 g in 1 TUBEOINTMENT146
41250-679-58triple antibioticplus pain relief1 in 1 CARTONOINTMENT16
41250-679-64triple antibioticplus pain relief28 g in 1 TUBEOINTMENT286

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
PRAMOXINEACTIVE MOIETY068X84E056TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-679TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 4 package rows20241101_d97a69e8-4058-4c77-b628-ad3e2b97a620.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 5 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ora Zen Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incabbf8c34-87cb-4366-9840-7264a5114b542026-03-11WarningsExact identifier
application number: M004
FM-24 FOAMINGCHLOROXYLENOLPeople's Janitorial Supplyb3c2e174-6099-ba08-e053-2995a90a72902026-03-10WarningsExact identifier
application number: M004
doubleantibioticointmentBACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC4eb5202e-8e5b-6d31-e054-00144ff88e882026-03-04WarningsExact identifier
application number: M004
Neomycin SulfateNEOMYCIN SULFATEAldermed Inc.4978bb06-8b7c-9a44-e063-6294a90ac4cf2026-02-12WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENatureplex LLCfbb64891-2219-451d-96b0-e7c0430fadda2026-02-12WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATUS PHARMACEUTICALS INCf64b3564-ea3c-4316-8f00-f92c08dcad352026-02-04WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, AND PRAMIXINE HCLVeridian Healthcared2374664-4668-4da5-9df7-44e6e421ad542026-01-29WarningsExact identifier
application number: M004
TheraCare Bacitracin ZincFIRST AID ANTIBIOTICVeridian Healthcare8217648d-5acb-4a1e-913f-43695f4e01ad2026-01-29WarningsExact identifier
application number: M004
Equate First Aid Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart907d44c5-cbd1-4d13-8c5c-c164f7a536e52026-01-29WarningsExact identifier
application number: M004
Natureplex Antibiotic plus PainBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex, LLC317acec2-8ab7-4b62-9d72-f98cab4f979c2026-01-29WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4963f926-3d48-36de-e063-6294a90a9acc2026-01-27WarningsExact identifier
application number: M004
A-Cute Derm AntisepationBENZETHONIUM CHLORIDEABBE Laboratories, Inc.d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec2026-01-24WarningsExact identifier
application number: M004
A-Cute Derm B-KleerBENZETHONIUM CHLORIDEABBE Laboratories, Inc.544333fe-6c3a-485b-b899-e029d97ea9622026-01-24WarningsExact identifier
application number: M004
Brace ReliefBENZOCAINEInfaLab,Incd7e57d67-4234-44a9-bbd3-72e99cd5bdb32026-01-16WarningsExact identifier
application number: M004
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
application number: M004
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsExact identifier
application number: M004
Hermon bed sore and pressure sore creamCALENDULA OFFICINALIS1X HPUS 1.5%Beautivity LLC48053402-b6c8-0443-e063-6294a90abce72026-01-10WarningsExact identifier
application number: M004
Walgreens Arthritis Pain Relief Capsaicin AnalgesicCAPSAICINWalgreen Companyda818dd5-bf64-46c2-a3ad-440b2874edbb2026-01-09WarningsExact identifier
application number: M004
QS Plus Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEABC Compounding Co., Inc.343f9139-47bc-44b0-9da1-d9d6f6334bc72026-01-06WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATEMelaleuca, Inc.65ae4607-689d-6056-e053-2a91aa0aff562025-12-31WarningsExact 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 OintmentPSNd97a69e8-4058-4c77-b628-ad3e2b97a6206
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDd97a69e8-4058-4c77-b628-ad3e2b97a6206
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYd97a69e8-4058-4c77-b628-ad3e2b97a6206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-679-16412500679162 TUBE in 1 CARTON (41250-679-16) / 28 g in 1 TUBE (41250-679-64) 2 tube2010-03-170000-00-00NoNoCurrent
41250-679-58412500679581 TUBE in 1 CARTON (41250-679-58) / 14 g in 1 TUBE1 tube2010-03-170000-00-00NoNoCurrent
41250-679-644125006796428 g in 1 TUBE28 gHistorical