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 28 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.492793db-7dc2-8313-e063-6394a90a52bf2026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4928615e-d1a9-72b8-e063-6394a90aa7ed2026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4943e51a-bb8e-745a-e063-6294a90a0a3d2026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Anti-bacterial Hand WipesANTI-BACTERIAL HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.494b09a4-4982-13bf-e063-6394a90a486f2026-01-26WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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
OfloxacinOFLOXACINA-S Medication Solutions537c6351-c7f1-47c9-95de-011bac8507682026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
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

Reported adverse events (FAERS/openFDA)#

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