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

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 Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui213626, 308512

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

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