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 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FifthPulse Hydrocortisone 4ozHYDROCORTISONEFront Pharmaceutical PLC39fb29c8-6a28-e87e-e063-6294a90a78da2025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEFred's, Inc.41ee7a50-d36b-4214-b6f8-44f47ab44a842025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATELidl US, LLC98389314-c2cf-4510-ab3d-41c4c47200192025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN BPublix Super Markets Inc72bdb96c-af93-4a9b-93d9-81a94b6ff7562025-07-15WarningsExact identifier
application number: M004
Live Better Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEThe Great Atlantic & Pacific Tea Company7e7a0b4c-67a9-42f3-aacd-2606fde250902025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETopco Associates LLC55a8a52c-4d03-417d-9283-406f6879bcb52025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEFRED'S, INC.a44db5d1-7a74-44aa-9aa7-6247e771aaf22025-07-15WarningsExact identifier
application number: M004
Shopko Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEShopko Stores Operating Co., LLC5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa2025-07-15WarningsExact identifier
application number: M004
sunmark triple antibiotic plus pain reliefPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC941a6a71-e898-4af3-989a-6d3aa32243382025-07-15WarningsExact identifier
application number: M004
TopCare Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC0fc0dbc6-ca1d-42be-8016-68e64f1197062025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalgreen Companye2b7fc5b-c796-4ed1-aea7-4c810df250d52025-07-15WarningsExact identifier
application number: M004
Publix antibiotic plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEPublix Super Markets Incd0193bf1-a257-490e-a058-5e6a514981da2025-07-15WarningsExact identifier
application number: M004
Live Better Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEThe Great Atlantic & Pacific Tea Company7d3435ad-7d73-4db6-8019-3040b3dadfa92025-07-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWal-Mart Stores, Inc.f5199476-1ce2-4a82-9685-40d78b7a89352025-07-14WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC38414fff-8dad-44d0-9dfa-f89a63ef9b442025-07-14WarningsExact identifier
application number: M004
sunmark double antibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEStrategic Sourcing Services LLC2868de5c-4894-45ee-9647-9acd3bde7cfc2025-07-14WarningsExact identifier
application number: M004
Live Better Bacitracin ZincBACITRACIN ZINCThe Great Atlantic & Pacific Tea Company6915940c-2eae-445c-ba58-e39d221e9d3d2025-07-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSTRATEGIC SOURCING SERVICES LLC4594948d-1f25-4d3c-a615-9e6edda05a102025-07-11WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Bacitracin ZincBACITRACIN ZINCAmerisourceBergen3fb302b5-7273-412c-a2ba-b76183e3f1792025-07-11WarningsExact identifier
application number: M004
TopCare Bacitracin ZincBACITRACIN ZINCTopco Associates LLC5b59e26d-cc25-49a6-ac8b-f79398e18f2d2025-07-07WarningsExact 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