NDC 0517-0761 - Ofloxacin

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
0517-0761
Package NDCs from labels
0517-0761-01
Manufacturer
American Regent, Inc. | PharmaForce, Inc.
Effective date
2010-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)American Regent, Inc. | PharmaForce, Inc.2010-07-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0761-012019-10-21C16284748780-1956f9ecf-c04e-621f-e053-dbdaa90a74adOFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0761-01Ofloxacin10 mL in 1 BOTTLESOLUTION/ DROPS101
0517-0761-01Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0761OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]12 package rows20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.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 77 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOJO E2 Foam Handwash with BAKBENZALKONIUM CHLORIDEGOJO Industries, Inc.f18732bd-65c7-4e11-b364-054b7e7425052024-12-03WarningsExact identifier
unii: F5UM2KM3W7
Junior MovesANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB METSilver Star Brands822d5481-7854-3fe7-e053-2a91aa0abf552024-12-03WarningsExact identifier
unii: 451W47IQ8X
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company464c2d78-5c88-4668-a039-56dd3c1c9b202024-12-03Exact identifier
unii: 451W47IQ8X
Aquabain Antibacterial Passion BerrysBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.aee5d7c2-93b3-f55e-e053-2995a90af72e2024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Aquabain Antibacterial Fresh and RelaxBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d3086-7902-2837-e053-2995a90a39df2024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Aquabain Antibacterial GrapefruitBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f49-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Aquabain Antibacterial Red FruitsBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.b04d4c11-1f4d-06c4-e053-2995a90a1e482024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Liquid Hand OatmealBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e1c5f6-195c-16d6-e063-6394a90abb862024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Liquid Hand Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2289d-60f4-260c-e063-6394a90a96f62024-12-02WarningsExact identifier
unii: F5UM2KM3W7
Jabonito Kids Green Apple LiquidBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.021bc525-3ebe-efc2-e063-6394a90a3fe32024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Shower Gel Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e4ff0e-ef63-ef3b-e063-6294a90aa2b82024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Vitamin E Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe9270c0-bf6b-f0ff-e053-6394a90ae8f12024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Liquid Hand CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2e51b-212b-368e-e063-6294a90a871c2024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Fresh Energy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe80635d-9594-abf3-e053-6394a90aa78b2024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Shower Gel CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e36111-ed4e-12de-e063-6294a90af6392024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Creamy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe7fde7e-82fc-c13f-e053-6394a90aff682024-12-02WarningsExact identifier
unii: F5UM2KM3W7
DK12 Oatmeal Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe16387b-1b16-1f41-e053-6294a90ae2c02024-12-02WarningsExact identifier
unii: F5UM2KM3W7
XX Health ProLACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHURSilver Star Brands4d11a65e-696a-0727-e054-00144ff88e882024-12-02WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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