FDA.reportPublic FDA data

Neosporin Pain Itch Scar

Product NDC
69968-0093
11-digit product format
699680093
Labeler code
69968
Product ID
69968-0093_21702506-042e-a902-e063-6294a90acaf9
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/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 Pain Itch Scar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui1359350

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0093-1Neosporin Pain Itch Scar1 in 1 CARTONOINTMENT19
69968-0093-1Neosporin Pain Itch Scar28.3 g in 1 TUBEOINTMENT28.39
69968-0093-2Neosporin Pain Itch Scar14.2 g in 1 TUBEOINTMENT14.29
69968-0093-2Neosporin Pain Itch Scar1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0093-1GM - Gram69968-009322f4a10b-dc5b-443b-a619-af35a79b7b9e12022-06-06
69968-0093-2GM - Gram69968-00934f290a35-3e56-4114-8546-99214fe74e5812020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0093NEOSPORIN PAIN ITCH SCAR (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 4 package rows20241115_55392c48-b5d8-44cd-8c10-6d8668349848.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN55392c48-b5d8-44cd-8c10-6d86683498489
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD55392c48-b5d8-44cd-8c10-6d86683498489
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY55392c48-b5d8-44cd-8c10-6d86683498489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0093-1699680093011 TUBE in 1 CARTON (69968-0093-1) / 28.3 g in 1 TUBE1 tube2016-01-150000-00-00NoNoCurrent
69968-0093-2699680093021 TUBE in 1 CARTON (69968-0093-2) / 14.2 g in 1 TUBE1 tube2016-01-150000-00-00NoNoCurrent