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 97 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
ElimiShield Hunt Core Body Foam for HuntersBENZALKONIUM CHLORIDEBryson Industries, Inc.b5dcf071-8de1-44db-b065-02e2a45aa0902023-11-09WarningsExact identifier
unii: F5UM2KM3W7
ElimiShield Home and Outdoor Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEBryson Industries Inc.affeb47c-0e10-7f04-e053-2a95a90a4f1f2023-11-09WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
unii: F5UM2KM3W7
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
unii: F5UM2KM3W7
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: QTT17582CB
ofloxacinOFLOXACINA-S Medication Solutions48dc8354-9a36-427b-ade9-818db6bfb01b2023-11-07Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Wet WipesBENZALKONIUM CHLORIDEZhejiang Ayan Biotech Co.,Ltd.21b48552-e624-455c-938f-8151e58d80e02023-11-06WarningsExact identifier
unii: F5UM2KM3W7
TRI-SOFT SOFTENINGBENZALKONIUM CHLORIDEClinical Therapeutic Solutions3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb2023-11-05WarningsExact identifier
unii: F5UM2KM3W7
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
Ahh SleepCOFFEA CRUDAMicro Balance Health Products08ea860f-0183-8ce8-e063-6394a90a582b2023-10-30WarningsExact identifier
unii: QTT17582CB
Hygiene Clean Unscented Clean Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569c604-7ba2-88e5-e053-2a95a90a9a0c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Balsam Fir Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb56a0275-1650-23a8-e053-2995a90a791c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffbcf06-4b52-e38d-e053-2995a90a5dbf2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lilac Garden Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe3527ae-ed2c-6b75-e053-2a95a90ab6ff2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda8ccbb-f771-d897-e053-2995a90ada2a2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lavender Blossom Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70e7cf-af9c-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Luxury Clean hand Sanitizer on the go and car safeBENZALKONIUM CHLORIDEUSA Broom LLCbbb44d63-ac8e-0d39-e053-2a95a90a319a2023-10-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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