FDA.reportPublic FDA data

Neosporin Plus Lidocaine

Product NDC
69968-0731
11-digit product format
699680731
Labeler code
69968
Product ID
69968-0731_44502ea9-e561-d454-e063-6294a90a4b10
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B, Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-30
Substance
LIDOCAINE; BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
40; 500; 3.5; 10000 mg/g; [iU]/g; mg/g; [iU]/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Neosporin Plus Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308498Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e450b6a1-a8da-e5db-e053-2995a90a0ef0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
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
69968-0731-1Neosporin Plus Lidocaine14.2 g in 1 TUBEOINTMENT14.27
69968-0731-1Neosporin Plus Lidocaine1 in 1 CARTONOINTMENT17
69968-0731-2Neosporin Plus Lidocaine1 in 1 CARTONOINTMENT17
69968-0731-2Neosporin Plus Lidocaine28.3 g in 1 TUBEOINTMENT28.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0731NEOSPORIN PLUS LIDOCAINE (BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE) OINTMENT [KENVUE BRANDS LLC]6Current NDC, 4 package rows20241120_e450b6a1-a8da-e5db-e053-2995a90a0ef0.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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308498bacitracin 500 UNT / lidocaine 40 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentPSNe450b6a1-a8da-e5db-e053-2995a90a0ef07
308498bacitracin 0.5 UNT/MG / lidocaine 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Topical OintmentSCDe450b6a1-a8da-e5db-e053-2995a90a0ef07
308498bacitracin 500 UNT / lidocaine 40 MG / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 10,000 UNT per GM Topical OintmentSYe450b6a1-a8da-e5db-e053-2995a90a0ef07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0731-1699680731011 TUBE in 1 CARTON (69968-0731-1) / 14.2 g in 1 TUBE1 tube2023-01-30NoNoCurrent
69968-0731-2699680731021 TUBE in 1 CARTON (69968-0731-2) / 28.3 g in 1 TUBE1 tube2026-01-01NoNoCurrent