FDA.reportPublic FDA data

Neosporin Original

Product NDC
69968-0634
11-digit product format
699680634
Labeler code
69968
Product ID
69968-0634_21fa7843-fca7-30ab-e063-6294a90ad79e
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-04
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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

Additional Listing Data#

Finished product
Yes
Brand name base
Neosporin Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0634-1Neosporin Original0.9 g in 1 POUCHOINTMENT0.93
69968-0634-9Neosporin Original144 in 1 CARTONOINTMENT1443
69968-0634-9Neosporin Original0.9 g in 1 POUCHOINTMENT0.93

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0634-1EA - Each69968-063448e340e7-2585-45b5-b631-d2063cb36f3612022-11-07
69968-0634-9EA - Each69968-0634e160c685-db85-4aee-98c2-f7ebc5edf80412022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0634NEOSPORIN ORIGINAL (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [KENVUE BRANDS LLC]3Current NDC, Legacy NDC, 3 package rows20241116_f07d3bca-4312-46ed-b0c4-f886c01bd095.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNf07d3bca-4312-46ed-b0c4-f886c01bd0953
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf07d3bca-4312-46ed-b0c4-f886c01bd0953
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf07d3bca-4312-46ed-b0c4-f886c01bd0953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0634-169968063401.9 g in 1 POUCH (69968-0634-1) 2021-01-040000-00-00NoNoCurrent
69968-0634-969968063409144 POUCH in 1 CARTON (69968-0634-9) / .9 g in 1 POUCH144 pouch2021-01-040000-00-00NoNoCurrent