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 73 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OfloxacinOFLOXACINNuCare Pharmaceuticals, Inc.51f3d155-36df-4c40-e054-00144ff8d46c2024-12-24Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
TREE ANTIGENPOPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLENatural Creations, Inc8040ab36-90eb-4076-a478-9b82ccfa4ec92024-12-23WarningsExact identifier
unii: 451W47IQ8X
Sterile Hypertonic Saline Solution 7 Sodium ChlorideSODIUM CHLORIDEJOONEM LLCe7110525-9f9b-5b68-e053-2995a90ac0342024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC49309411-9af4-4f19-a3bf-dbeabc1068272024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLCba0868f6-d3de-40e2-bcb3-144fa53062c72024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC9d83f477-ebbc-4248-8445-769178181d4f2024-12-23WarningsExact identifier
unii: 451W47IQ8X
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
unii: F5UM2KM3W7
ofloxacinOFLOXACINLifestar Pharma LLC871d63f4-41c1-4b30-903c-11fbf0d4c1f82024-12-23Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
ARRAY Plum Scent Antibacterial Foam HandwashBENZALKONIUM CHLORIDEGordon Food Service, Inc.62ef137b-a2fe-4379-9d82-ff6b59667b7e2024-12-20WarningsExact identifier
unii: F5UM2KM3W7
AgroBac Pure FOAMBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.8b70a920-e63a-418f-8b79-f57eb5576b1a2024-12-20WarningsExact identifier
unii: F5UM2KM3W7
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
unii: F5UM2KM3W7
AFFEX Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEAfflink, Inc.3f51700a-0e8f-4091-ab0d-6751364304a42024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRIME SOURCE Antibacterial Foam HandwashBENZALKONIUM CHLORIDEBUNZLeb626be7-baec-447c-97e1-534494beb0202024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRIME SOURCE SELECT Plum Antibacterial Foam Hand So apBENZALKONIUM CHLORIDEBUNZLd56dbf55-9630-4d00-9dc5-68e55f48e7932024-12-19WarningsExact identifier
unii: F5UM2KM3W7
DON Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEEdward Don & Company5b6852cd-b45a-4262-b454-041f223fa3f82024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRIME SOURCE ULTRA Energy Plum Antibacterial Foam Hand So apBENZALKONIUM CHLORIDEBUNZLfdb354e7-564f-4b0e-8bb7-7895521988182024-12-19WarningsExact identifier
unii: F5UM2KM3W7
RENOWN Antibacterial Plum HandwashBENZALKONIUM CHLORIDEInterline Brands, Inc.2b876c51-358a-4bb2-8f35-317ed7af47402024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Victoria Bay Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEDade Paper & Bag, LLC51d05dca-ffe4-4f1c-a883-43c436dbf7402024-12-19WarningsExact identifier
unii: F5UM2KM3W7
BRIGHT SOLUTIONS Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEKel-San, Inc.844a80f3-9fd5-4688-81c8-494eb11a024a2024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Pro Formance Plum Perfection Antibacterial Foam S oapBENZALKONIUM CHLORIDEPro-Link, Inc.6bdc6f78-5ecd-4de7-9457-eda580c3a3e02024-12-19WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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