FDA.reportPublic FDA data

NDC 68071-4375-05 - Neomycin Polymyxin B Sulfates and Dexamethasone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-4375
Requested NDC
68071-4375-05
Package NDCs from labels
68071-4375-5, 68071-4375-05
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin Polymyxin B Sulfates and Dexamethasone - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-15Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2023-01-30Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-02-16Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-01-29Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4375-5Neomycin Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOXSUSPENSION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4375NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240608_691bc5ca-5d61-60c2-e053-2991aa0abb93.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 34 of 138 · 2,743 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation87288939-cc34-4437-94ab-dcb997d6acd52026-01-23WarningsExact identifier
unii: F5UM2KM3W7
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation10454042-ff2e-44ce-b2e2-436cc004897f2026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIaa5cc644-8911-393e-e053-2a95a90a406a2026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIaa5cf2af-0061-c04c-e053-2a95a90aeb972026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizer WipesJUNIPER CLEANKYNC Design LLCa73134a6-8b71-fb0d-e053-2995a90abc062026-01-23WarningsExact identifier
unii: F5UM2KM3W7
CaseysLavenderCASEYS HAND SOAP LAVENDER SCENTKYNC Design LLCb5bc8770-13ef-36dc-e053-2995a90a3f512026-01-23WarningsExact identifier
unii: F5UM2KM3W7
JuniperClean LavenderJUNIPER CLEAN HAND SOAP LAVENDERKYNC Design LLC0bf0000f-5c91-8731-e063-6294a90a52df2026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Everlit Survival Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3a03f7e6-cc74-22a2-e063-6394a90a5f9f2026-01-23WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS Sanitizing BODYBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incb9828d1e-e6e2-4d02-bfc6-7fd37c0836412026-01-23WarningsExact identifier
unii: F5UM2KM3W7
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1e927-3b65-372e-e053-2a95a90accdc2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1fcab-9d55-4272-e053-2995a90a3bd02026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1bbb2-18a3-2b00-e053-2995a90ace3c2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18ed1f-1428-49c9-e053-2a95a90ac4c82026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae1-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae5-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e0-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19269c-cd28-f12f-e053-2a95a90ab0162026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Liquid Hand Wash Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e2-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Drs. Pharmacy Triple Antibiotic AND BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOL PHARMA TECH, LLC Drs PHARMACY4928d9dd-542b-fe8b-e063-6294a90a92522026-01-22WarningsExact identifier
unii: 057Y626693
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.