FDA.reportPublic FDA data

NDC 55545-1003-2 - 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
55545-1003
Requested NDC
55545-1003-2
Package NDCs from labels
55545-1003-2, 55545-1003-1
Manufacturer
FDC Limited
Effective date
2017-11-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ofloxacin - FDC LimitedFDC Limited2017-11-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1003-1Ofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION53
55545-1003-1Ofloxacin1 in 1 CARTONSOLUTION13
55545-1003-2Ofloxacin1 in 1 CARTONSOLUTION13
55545-1003-2Ofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1003OFLOXACIN SOLUTION [FDC LIMITED]3Legacy NDC, 4 package rows20171122_b4d09b4d-bc6a-405b-91c8-e4246336a1f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [FDC LIMITED]2
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [FDC LIMITED]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION [FDC LIMITED]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION [FDC LIMITED]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION [FDC LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION [FDC LIMITED]2

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 9 of 106 · 2,106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand Wipes Lil Drug StoreBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.6ab0488c-02f3-4aa6-b6b3-d4f0d582b1672026-07-10WarningsExact identifier
unii: F5UM2KM3W7
PURELL HEALTHY SP 0.5pct BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, LLC97b7d732-3b33-4c60-b6d9-0f1d28dda4bf2026-07-09WarningsExact identifier
unii: F5UM2KM3W7
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
unii: F5UM2KM3W7
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
unii: F5UM2KM3W7
BAK 1 750BENZALKONIUM CHLORIDEMedical Chemical Corporationd1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca82026-07-02WarningsExact identifier
unii: F5UM2KM3W7
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
ANTISEPTIC WIPEBENZALKONIUM CHLORIDE WIPEDiamond Wipes International0a49c713-56da-af45-e063-6394a90a8fce2026-07-01WarningsExact identifier
unii: F5UM2KM3W7
Laura Lynn Foaming Fragrance and Dye Free Antibacterial HandBENZALKONIUM CHLORIDEIngles Markets, Inc.57e83a97-5b5f-8034-e063-6394a90a42a62026-07-01WarningsExact identifier
unii: F5UM2KM3W7
Laura Lynn Antibacterial Liquid HandBENZALKONIUM CHLORIDEIngles Markets, Inc.57ed13d7-0f68-ae4f-e063-6294a90ab7d22026-07-01WarningsExact identifier
unii: F5UM2KM3W7
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
unii: F5UM2KM3W7
Foaming Antibacterial HandBENZALKONIUM CHLORIDEIntercon Chemical Company556b74d3-d37d-9508-e063-6294a90ae89f2026-06-29WarningsExact identifier
unii: F5UM2KM3W7
ofloxacinOFLOXACIN OTICSportpharm LLC3f5972db-4eaf-4237-944d-8f63eff7b9b12026-06-26Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
OfloxacinOFLOXACINSt. Mary's Medical Park Pharmacy2d55b26d-9d12-ca29-e063-6294a90ab2372026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
PURELL SF607 Instant Hand SanitizingBENZALKONIUM CHLORIDEGOJO Industries, Inc.f29dcf99-9b5d-46f5-ac15-fd9c2f2318f42026-06-25WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact identifier
unii: F5UM2KM3W7
MOUTAIN DEW HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fbbdde-ef7b-0a8b-e063-6294a90ad9e42026-06-24WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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