FDA.reportPublic FDA data

Polysporin First Aid Antibiotic

Product NDC
69968-0060
11-digit product format
699680060
Labeler code
69968
Product ID
69968-0060_223d985d-1107-7dcc-e063-6394a90a94ab
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-09
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [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
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
Polysporin First Aid Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213626Internal RxNorm lookup
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
e0fcf83e-a374-4fc0-a629-873033054392Available 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
69968-0060-1Polysporin First Aid Antibiotic0.9 g in 1 PACKETOINTMENT0.94
69968-0060-2Polysporin First Aid Antibiotic1 in 1 CARTONOINTMENT14
69968-0060-2Polysporin First Aid Antibiotic28.3 g in 1 TUBEOINTMENT28.34
69968-0060-3Polysporin First Aid Antibiotic1 in 1 CARTONOINTMENT14
69968-0060-3Polysporin First Aid Antibiotic14.2 g in 1 TUBEOINTMENT14.24
69968-0060-9Polysporin First Aid Antibiotic0.9 g in 1 PACKETOINTMENT0.94
69968-0060-9Polysporin First Aid Antibiotic144 in 1 CARTONOINTMENT1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0060POLYSPORIN FIRST AID ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 7 package rows20241116_e0fcf83e-a374-4fc0-a629-873033054392.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 · 424 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
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSNe0fcf83e-a374-4fc0-a629-8730330543924
213626Polysporin 500 UNT / 10,000 UNT per GM Topical OintmentPSNe0fcf83e-a374-4fc0-a629-8730330543924
213626bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Ointment [Polysporin]SBDe0fcf83e-a374-4fc0-a629-8730330543924
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCDe0fcf83e-a374-4fc0-a629-8730330543924
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSYe0fcf83e-a374-4fc0-a629-8730330543924
213626Polysporin (bacitracin 0.5 UNT / polymyxin B 10 UNT) per MG Topical OintmentSYe0fcf83e-a374-4fc0-a629-8730330543924
213626Polysporin (bacitracin 500 UNT / polymyxin B 10,000 UNT) per GM Topical OintmentSYe0fcf83e-a374-4fc0-a629-8730330543924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0060-169968006001.9 g in 1 PACKET (69968-0060-1) 2013-07-090000-00-00NoNoCurrent
69968-0060-2699680060021 TUBE in 1 CARTON (69968-0060-2) / 28.3 g in 1 TUBE1 tube2013-07-090000-00-00NoNoCurrent
69968-0060-3699680060031 TUBE in 1 CARTON (69968-0060-3) / 14.2 g in 1 TUBE1 tube2013-07-090000-00-00NoNoCurrent
69968-0060-969968006009144 PACKET in 1 CARTON (69968-0060-9) / .9 g in 1 PACKET144 packet2013-07-090000-00-00NoNoCurrent