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 16 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEAmbition Power Brands5132bc70-bf3b-180c-e063-6394a90afdad2026-05-06WarningsExact identifier
unii: F5UM2KM3W7
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
HandsoapBENZALKONIUM CHLORIDETopco Associates LLCe60ff14a-f78d-c9fa-e053-2995a90a7f102026-05-05WarningsExact identifier
unii: F5UM2KM3W7
Kroger Springwater AntibacterialBENZALKONIUM CHLORIDEKroger Company01006967-d11c-d02a-e063-6394a90ad42c2026-05-04WarningsExact identifier
unii: F5UM2KM3W7
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
unii: F5UM2KM3W7
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
unii: F5UM2KM3W7
Winco FoodsBENZALKONIUM CHLORIDEWinCo Foods, LLCc98648f2-c6a4-64d9-e053-2995a90aa3522026-05-03WarningsExact identifier
unii: F5UM2KM3W7
Careone AmberBENZALKONIUM CHLORIDERetail Business Services, LLCcb8fdf26-8372-70d8-e053-2995a90a840a2026-05-03WarningsExact identifier
unii: F5UM2KM3W7
WalgreenBENZALKONIUM CHLORIDEWalgreen Coc992cf19-786c-d794-e053-2995a90af0672026-05-02WarningsExact identifier
unii: F5UM2KM3W7
WalgreenBENZALKONIUM CHLORIDEWalgreenead9641b-4d30-da10-e053-2995a90a60e72026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger AntibacterialBENZALKONIUM CHLORIDEKroger Company00ffe9f9-15c3-be46-e063-6394a90a3d352026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger Antibacterial LHSBENZALKONIUM CHLORIDEKroger Company0100d627-88e7-a80c-e063-6394a90a47972026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger AntibacterialBENZALKONIUM CHLORIDEKroger Company0100f324-0204-3aba-e063-6394a90a46932026-05-02WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS PHARMACY, INCe584a181-1226-5dda-e053-2a95a90ab6452026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care0970a4e2-c7b5-bcb7-e063-6394a90a43532026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
unii: F5UM2KM3W7
SCOTT FOAM HAND SANITIZERBENZALKONIUM CHLORIDEKimberly-Clark11234f21-04e4-4b16-88c3-51968a1cedca2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Summit 377Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDER.L. Williams Company50ae9765-2c2b-137f-e063-6294a90ae13a2026-04-30WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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