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 43 of 138 · 2,743 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zep Professional Mild ABBENZALKONIUM CHLORIDEZep Inc.b43b2607-a546-5109-e053-2a95a90a889e2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Fuzion FS Antimicrobial Foaming Hand CleanerBENZALKONIUM CHLORIDEZep Inc.b43e9dff-4260-26a5-e053-2995a90a85702025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Tranq Mdw AB FoamBENZALKONIUM CHLORIDEZep Inc.5c3c1ab7-96a7-6ca5-e053-2991aa0af2b92025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ZEP PEAR AB HSBENZALKONIUM CHLORIDEZep Inc.5bc1cc32-5d18-00a8-e053-2991aa0a0c812025-12-26WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL BERRY MEDLEYBENZALKONIUM CHLORIDEUniversal Distribution Center LLC0619a051-3f7d-4037-962c-e2e855a123422025-12-26WarningsExact identifier
unii: F5UM2KM3W7
YELLOW ESSENTIALS SANITIZING WIPES87039-001Gritt Commercial Inc.3d403feb-0d15-d6cd-e063-6394a90a15e62025-12-25WarningsExact identifier
unii: F5UM2KM3W7
Triple Allergy DefenseALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, LEMNA MINOR, LUFFA OPERCULATA, NATRUM MURIATICUM, POLYPORUS PINICOLA, SABADILLANenningers Naturals, LLCe1459ef4-6980-4b2b-94c1-6c896a9cb6bd2025-12-25WarningsExact identifier
unii: 451W47IQ8X
Dr. Nenninger Cold and Sinus SolutionALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLANenningers Naturals, LLC1e26b25c-5d93-4f69-aa9e-a187abd6d0352025-12-25WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
GoodEarth Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution LLC1c4ec3cb-b7a4-73c9-e063-6394a90afeda2025-12-24WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZERBENZALKONIUM CHLORIDETazza Brands East Inc.327b9971-808d-ff93-e063-6394a90adce42025-12-24WarningsExact identifier
unii: F5UM2KM3W7
CLEANZ ECO BAMBOO WIPESWIPESMcF Holdings LLCeb85292a-41a3-67b0-e053-2a95a90ab4612025-12-24WarningsExact identifier
unii: F5UM2KM3W7
ZEHN ANTISEPTIC SANITIZING WIPESBENZALKONIUM CHLORIDEZehn Wipes39771493-978e-18b6-e063-6294a90a42662025-12-24WarningsExact identifier
unii: F5UM2KM3W7
MG DermaFoamBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.4a43a605-f333-4c76-a476-476a9cc2e13a2025-12-23WarningsExact identifier
unii: F5UM2KM3W7
Sipa HAND SANITIZING WIPESBENZALKONIUM CHLORIDESipa Holdings USA, Inc.2c47f1a8-4416-fd21-e063-6394a90ae1672025-12-23WarningsExact identifier
unii: F5UM2KM3W7
tazza HAND SANITIZER KING WIPESBENZALKONIUM CHLORIDETazza Brands East, Inc.1c7d3d7b-64ca-4f91-e063-6294a90a04a72025-12-23WarningsExact identifier
unii: F5UM2KM3W7
ActivMendARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUMCearna, Inc.baefc5d4-a7e4-4ba2-e053-2995a90a4b862025-12-23WarningsExact identifier
unii: 451W47IQ8X
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
unii: F5UM2KM3W7
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial FoamBENZALKONIUM CHLORIDESC Johnson Professional USA Inc.df36ccda-b9cb-41ba-8d4d-56ec447e63df2025-12-23WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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