FDA.reportPublic FDA data

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 24 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.64c7d808-aaa0-4b8b-8fef-6285059939782026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.8fbbc798-ac00-4755-a2c2-5cd5b5c01ae42026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEMeijer, Inc.df4dbf38-669a-441a-bd6e-f5cc490d17d22026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Meijer, Inc.fbfb9940-0c17-4fdf-81f5-406d614da8722026-02-19Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antiseptic Foaming Hand SanitizerBENZALKONIUM CHLORIDETarget Corporation93d6e4df-9428-4557-b251-c7aa9bda34122026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDES. P. Richards Company9223a236-9e9e-42eb-a945-dfe629e4ae3f2026-02-18Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEWalmart Inc.25d227f8-2238-4f6f-aa40-b314d0179d882026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Light Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%United Natural Foods, Inc. dba UNFI36738761-293e-4864-bc08-87a5075e1ccf2026-02-17WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd902026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDE 0.13%Uline57c7bf8f-c17a-41b5-9b66-e4d16d6650a72026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEULINE5a4d6fb7-486a-448c-b379-726adf60e4112026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WashBENZALKONIUM CHLORIDE 0.13%Uline9e7a97a0-f3dd-40cf-b25e-8ebb656939262026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Foaming HandBENZALKONIUM CHLORIDEVeritiv Operating Company3b4dbfd0-f275-3502-e063-6294a90a84862026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEVeritiv Operating Company3b4f27c8-6a1c-2823-e063-6294a90a47ad2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Valu Merchandisers Companyfb9071d7-e44a-47fc-b76d-faf6220a57bf2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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