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 57 of 135 · 2,683 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CompleteBENZALKONIUM CHLORIDESimoniz Saniclean, LLC41ed32ea-5a3b-fa50-e063-6394a90a20c42025-10-27WarningsExact identifier
unii: F5UM2KM3W7
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
unii: F5UM2KM3W7
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
unii: F5UM2KM3W7
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
unii: F5UM2KM3W7
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
MaxitrolNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEHarrow Eye, LLCecfb954f-5554-0ad2-e053-2995a90a75162025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 309680
unii: 057Y626693
unii: 7S5I7G3JQL
unii: 19371312D4
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
unii: F5UM2KM3W7
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
United AirlinesBENZALKONIUM CHLORIDEFreshorize Ltda8d96b43-272a-9e49-e053-2995a90a3cc12025-10-23WarningsExact identifier
unii: F5UM2KM3W7
WastedBENZALKONIUM CHLORIDEFreshorize Ltd0c43b516-7608-c826-e063-6294a90ae4e32025-10-23WarningsExact identifier
unii: F5UM2KM3W7
Alaska AirlinesBENZALKONIUM CHLORIDEFreshorize Ltd.a8ed793e-988e-d815-e053-2995a90a3d312025-10-23WarningsExact identifier
unii: F5UM2KM3W7
Sani-Foam Foaming Non-Alcohol Hand SanitizerBENZALKONIUM CHLORIDEMulti-Clean2bea7ec7-e79e-8f34-e063-6294a90a96092025-10-23WarningsExact identifier
unii: F5UM2KM3W7
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
unii: F5UM2KM3W7
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA54c1d306-dc3b-2885-e054-00144ff8d46c2025-10-22WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
DEXAMETHASONEDEXAMETHASONEAdvagen Pharma Ltd.3c1729db-8ba3-4cba-9eff-ab4ae2c061c22025-10-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e541ebf-2f7e-4cc0-9928-780353aa76572025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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