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 85 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gum TherapyACONITUM NAPELLUS, ARNICA MONTANA, BISMUTHUM SUBNITRICUM, BORAX, CALCAREA FLUORICA, CALENDULA OFFICINALIS, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, KALI PHOSPHORICUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NATRUM MURIATICUM, SEPIADeseret Biologicalsceb5203b-b4c8-4c7b-8e18-ccbff5034fc12024-08-29WarningsExact identifier
unii: 451W47IQ8X
WhiskCare 377 FreeBENZALKONIUM CHLORIDEWhisk Products, Inc.0bf163a6-0239-932c-e063-6394a90a12ab2024-08-28WarningsExact identifier
unii: F5UM2KM3W7
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, BORAX, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals5c741edc-f3ce-4e43-bb3e-fb73166214062024-08-28WarningsExact identifier
unii: 451W47IQ8X
Upper Respiratory SupportALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, SALVIA OFFICINALIS, DULCAMARA, EUPHRASIA OFFICINALIS, HYDRASTIS CANADENSIS, NATRUM MURIATICUM, SABADILLA, VISCUM ALBUM, MUCOSA NASALIS SUIS, ACONITUM NAPELLUS, AMMONIUM CARBONICUM, ARSENICUM IODATUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (PRATENSIS), RHUS TOXDeseret Biologicals, Inc.882a284f-aa25-40cf-8aff-fe4c38ff3f0a2024-08-23WarningsExact identifier
unii: 451W47IQ8X
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
unii: F5UM2KM3W7
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unileverb9f65122-4037-de0b-e053-2995a90ae5102024-08-16WarningsExact identifier
unii: F5UM2KM3W7
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
unii: F5UM2KM3W7
ofloxacinOFLOXACIN OTICA-S Medication Solutions71949588-42e2-446c-b7ec-904c09b2f95f2024-08-07Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
Proclean Foaming Antibacterial NexaBENZALKONIUM CHLORIDEEcolab Inc.8c0d8188-67ee-4b2c-9975-4df4511070ee2024-08-06WarningsExact identifier
unii: F5UM2KM3W7
EcoCare 280BENZALKONIUM CHLORIDEEcolab Inc.89e45f4c-7599-4070-9f7c-07c7286e3c6f2024-08-06WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.63a5dd9f-9354-4d8b-a75c-d30f65ca19d72024-08-05WarningsExact identifier
unii: F5UM2KM3W7
ofloxacinOFLOXACINNuCare Pharmaceuticals,Inc.ff9776b3-a244-e1ea-e053-6294a90aeb7b2024-08-05Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
PROCLEANBENZALKONIUM CHLORIDEEcolab Inc.60da90e4-3467-4aea-9c44-09a9ef7189952024-08-05WarningsExact identifier
unii: F5UM2KM3W7
SwisherBENZALKONIUM CHLORIDEEcolab Inc.29cb072c-5273-4121-9288-2228335590e52024-08-05WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.acdce645-5a74-4a45-aa7b-6f08bc8c89af2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
SwisherBENZALKONIUM CHLORIDEEcolab Inc.04e2f617-0643-4097-8780-b64c58c5b56c2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.14ba88a3-af32-4191-afed-cdcc7eb8ad6a2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
EcolabBENZALKONIUM CHLORIDEEcolab Inc.02d45eff-398a-44fe-bd56-5257cf596e7d2024-08-05WarningsExact identifier
unii: F5UM2KM3W7
Swisher TFBENZALKONIUM CHLORIDEEcolab Inc.d2ac8ef9-3426-4559-a8d3-6b6b5a638ef22024-08-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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