FDA.reportPublic FDA data

Simply Neosporin

Product NDC
69968-0612
11-digit product format
699680612
Labeler code
69968
Product ID
69968-0612_26c98f09-2db4-88dc-e063-6294a90a8c9f
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
2020-02-24
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [iU]/g; [iU]/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
Simply Neosporin
Brand name suffix
First Aid Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
POLYMYXIN B SULFATE10000 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

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
69968-0612-1Simply NeosporinFirst Aid Antibiotic14.2 g in 1 TUBEOINTMENT14.25
69968-0612-1Simply NeosporinFirst Aid Antibiotic1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0612-1GM - Gram69968-06127a4a5ee1-b9f9-4d79-8a73-2c32cd0fe7bc12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0612SIMPLY NEOSPORIN FIRST AID ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 2 package rows20250112_68bfecea-095f-4d3f-b077-d86e1b9f1faa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN68bfecea-095f-4d3f-b077-d86e1b9f1faa5
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD68bfecea-095f-4d3f-b077-d86e1b9f1faa5
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY68bfecea-095f-4d3f-b077-d86e1b9f1faa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0612-1699680612011 TUBE in 1 CARTON (69968-0612-1) / 14.2 g in 1 TUBE1 tube2020-02-240000-00-00NoNoCurrent