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 7 of 106 · 2,106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SoftSoap Antibacterial with moisturizers Crisp CleanBENZALKONIUM CHLORIDEColgate-Palmolive Company65d4de78-fa6f-4838-8217-0e3599cc09a02026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd56dc7a8-bee3-4eca-95cf-f1b0a6e2aad22026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
unii: F5UM2KM3W7
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
FoamyiQ Non-Alcohol Hand SanitizerFOAMYIQ NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8a2af2-0572-19b1-e053-2995a90a23ae2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Biodegradable Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Incd4e03834-d487-9f5d-e053-2a95a90a5e282026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Sanitizing Wipes Alcohol Free Fragrance FreeBENZALKONIUM CHLORIDEGoodEarth Distribution Llcd4de3289-5a00-5df4-e053-2995a90a9f3f2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEERC ACQUISITION, INC.00cd6f41-c9a8-b384-e063-6394a90a85752026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution Llcb92744a3-32aa-4aab-ab65-eba9a90e4c572026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc00ccdb15-7db9-0102-e063-6294a90a3ee32026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Hand Sanitizing Wipes Fragrance FreeBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc9886fa20-65c7-4deb-a1ae-0c3e52ba887e2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Ince805a12d-2bd8-4331-bd81-02c99d057acf2026-07-17WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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