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 6 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
Jelly SmackBENZALKONIUM CHLORIDEVULCAN MICROBIAL CORPORATIONeb79e11a-6c29-556b-e053-2a95a90a728a2026-07-29WarningsExact identifier
unii: F5UM2KM3W7
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: F5UM2KM3W7
AEROAIDBENZALKONIUM CHLORIDEAero Healthcare US LLCc9d55d86-0a4e-4c44-96e8-8d13fd16c54d2026-07-24WarningsExact identifier
unii: F5UM2KM3W7
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
unii: F5UM2KM3W7
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Germfree24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfb43545b-6ddc-49fb-86dd-17cd1a925a782026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Pharma-Care Skin Preparation ClothsBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc324ec648-59f9-46c2-ab7a-7ec6ba42dd422026-07-22WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc0c73f042-47e5-4eba-ba59-52aabf8f45312026-07-22WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc91655320-7d8e-4024-b8f3-511d33d059f92026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ-Free 24 SanitizingBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc1ef9c150-f885-4b0e-8b69-82c4832fab912026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS HAND SANITIZERBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Ince174f231-73df-464b-bd92-23222659df242026-07-21WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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