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 71 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc00179db3-5a76-4724-a848-28e71eb580a62025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc3e65e67d-c7d0-2fcb-e054-00144ff8d46c2025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Aqua Clear 2X UltraBENZALKONIUM CHLORIDESante Manufacturing Incd5d15729-1dc1-2b44-e053-2a95a90a26c52025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Sipa hand sanitizer S.pray with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbc3c5d-c231-9024-e053-6294a90a9c592025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ormadus Foodservice Antibacterial FoamBENZALKONIUM CHLORIDESC Johnson Professional USA Inc71cd4be3-1cdf-4e49-be7b-405fe12288d22025-01-07WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial BathingBENZALKONIUM CHLORIDECardinal Health, Inc.586463f3-d117-47ae-bbab-f7caff1f5fa82025-01-06WarningsExact identifier
unii: F5UM2KM3W7
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
unii: F5UM2KM3W7
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufcaturing Inc205eb8f9-55fd-266e-e063-6294a90a4b3e2025-01-03WarningsExact identifier
unii: F5UM2KM3W7
Sipa Foam hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcb9fe65-837c-011b-e053-6294a90a46052025-01-02WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufacturing Inc3e64d344-8883-0235-e054-00144ff8d46c2025-01-02WarningsExact identifier
unii: F5UM2KM3W7
Dial refresh and renew Antibacterial whiteBENZALKONIUM CHLORIDEHenkel Corporationf7f5ed83-1b9b-230a-e053-6394a90ad2ae2025-01-01WarningsExact identifier
unii: F5UM2KM3W7
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Headache EaseAUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIASilver Star Brandsc689fb16-6200-ac94-e053-2995a90a703d2025-01-01WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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