FDA.reportPublic FDA data

Neosporin Plus Pain Relief

Product NDC
69968-0801
Requested package NDC
69968-0801-9
11-digit product format
699680801
Labeler code
69968
Product ID
69968-0801_4d4ac333-666f-cb35-e063-6294a90a35ef
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-01
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 Pain Relief
Brand name suffix
Clubtray
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4545718-8643-a340-e053-2995a90a0079Available 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
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
69968-0057-1Neosporin Plus Pain ReliefClubtray1 in 1 CARTONOINTMENT10 mg in 1g3
69968-0057-1Neosporin Plus Pain ReliefClubtray28.3 g in 1 TUBEOINTMENT28.3 g10 mg in 1g3
69968-0057-2Neosporin Plus Pain ReliefClubtray14.2 g in 1 TUBEOINTMENT14.2 g10 mg in 1g3
69968-0057-2Neosporin Plus Pain ReliefClubtray1 in 1 CARTONOINTMENT10 mg in 1g3
69968-0801-9Neosporin Plus Pain ReliefClubtray1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0801NEOSPORIN PLUS PAIN RELIEF CLUBTRAY (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]2Current NDC, 5 package rows20241116_f4545718-8643-a340-e053-2995a90a0079.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 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSNf4545718-8643-a340-e053-2995a90a00793
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDf4545718-8643-a340-e053-2995a90a00793
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYf4545718-8643-a340-e053-2995a90a00793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0801-9699680801091 KIT in 1 PACKAGE (69968-0801-9) * 1 TUBE in 1 CARTON (69968-0057-1) / 28.3 g in 1 TUBE * 1 TUBE in 1 CARTON (69968-0057-2) / 14.2 g in 1 TUBE1 kit2022-06-01NoNoCurrent