FDA.reportPublic FDA data

NDC 55545-1011-2 - ciprofloxacin

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
55545-1011
Requested NDC
55545-1011-2
Package NDCs from labels
55545-1011-1, 55545-1011-2, 55545-1011-3
Manufacturer
FDC Limited
Effective date
2018-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ciprofloxacin - FDC LimitedFDC Limited2018-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1011-1ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-1ciprofloxacin2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.51
55545-1011-2ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-2ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION51
55545-1011-3ciprofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION101
55545-1011-3ciprofloxacin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1011CIPROFLOXACIN SOLUTION [FDC LIMITED]1Legacy NDC, 6 package rows20181101_0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc.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 72 of 72 · 1,440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Callington Anti-Bacterial Hand SanitiserBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.1c6650c9-29fa-4fba-8442-fe294a2087c02019-02-25WarningsExact identifier
unii: F5UM2KM3W7
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdf24efa3-c9a0-4f40-92ce-cc71c708931b2018-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e74496f-4dca-4471-be32-c0a14bc627502018-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
3ed875b7-75eb-4ba1-9a36-80f13fb734540e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc2018-10-08Warnings, Adverse reactionsExact identifier
spl id: 3ed875b7-75eb-4ba1-9a36-80f13fb73454
spl set id: 0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc
Harris Teeter Spring Fresh Body WashBENZALKONIUM CHLORIDEHarris Teeter401106d1-a701-48bf-b8fc-1bc0454c41392018-07-26WarningsExact identifier
unii: F5UM2KM3W7
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: F5UM2KM3W7
CiprofloxacinCIPROFLOXACINAphena Pharma Solutions - Tennessee, LLCc7bc0d20-526c-48ea-b23a-cea9eb7080ff2018-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Soft Care SentryBENZALKONIUM CHLORIDEDiversey, Inc.f0686b7b-2f41-4656-8eb2-09483571a1bc2018-03-01WarningsExact identifier
unii: F5UM2KM3W7
Acetic AcidACETIC ACIDBaxter Healthcare Corporation41bc12af-fac5-4ac1-b907-dcb3e35a054c2018-02-02Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Refresh Sanitizing Towlette Organic Grapefruit SplashBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC50843247-c769-410e-930f-4a281a499c302018-01-29WarningsExact identifier
unii: F5UM2KM3W7
Recharge Sanitizing Towlette Organic Peppermint SurgeBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC3f8ae3b7-a2c4-48e8-a6eb-a3e38c5797a02018-01-29WarningsExact identifier
unii: F5UM2KM3W7
Relax Sanitizing Towlette Organic Lavender CalmBENZALKONIUM CHLORIDEGIOVANNI COSMETICS INC70914fc3-1ada-450d-a4eb-7db283030d5f2018-01-29WarningsExact identifier
unii: F5UM2KM3W7
Byotrol Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC09edbc17-c443-4b0d-9c28-c4b8233c4d1a2017-12-14WarningsExact identifier
unii: F5UM2KM3W7
First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies25ebf112-8ac3-4402-9a87-00e454ab7efa2017-11-30WarningsExact identifier
unii: F5UM2KM3W7
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: Q40Q9N063P
Glucose Control T015SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMGuangzhou Renuma Medical Systems Co., Ltd3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b2017-10-26WarningsExact identifier
unii: Q40Q9N063P
Hand SanitizerBENZALKONIUM CHLORIDEAdvanced Hygienics LLC1b225968-aff7-4959-89e1-a8edabb4d6702017-05-22WarningsExact identifier
unii: F5UM2KM3W7
CVS Pain Relieving First Aid AntisepticLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy454b1773-eda8-5610-e054-00144ff88e882017-01-04WarningsExact identifier
unii: F5UM2KM3W7
CVS Pharmacy Sensitive Medicated CreamBENZOCAINE, BENZALKONIUM CHLORIDECVS Pharmacy454c3458-7e40-0e5e-e054-00144ff8d46c2017-01-04WarningsExact identifier
unii: F5UM2KM3W7
Sit CleanBENZALKONIUM CHLORIDESit Cleanef2b12f8-89b3-47c4-88bd-8712a84cfc452016-08-18WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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