FDA.reportPublic FDA data

NDC 60635-018 - Varithena

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
60635-018
Package NDCs from labels
60635-018-01
Manufacturer
Boston Scientific Corporation | Boston Scientific Limited (Ireland) Cork
Effective date
2026-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Boston Scientific Corporation | Boston Scientific Limited (Ireland) CorkBoston Scientific Corporation | Boston Scientific Limited (Ireland) Cork2026-10-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60635-018-01Varithena18 mL in 1 CANISTERINJECTABLE FOAM18 mL10 mg in 1mL17
60635-018-01Varithena18 mL in 1 CANISTERINJECTABLE FOAM18 mL10 mg in 1mL17
60635-018-01Varithena18 mL in 1 CANISTERINJECTABLE FOAM18 mL10 mg in 1mL17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60635-018VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]14Unmatched20241012_dfd6b4a0-b0dc-11e2-9e96-0800200c9a66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLIDOCANOLACTIVE INGREDIENT0AWH8BFG9AVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
POLIDOCANOLACTIVE MOIETY0AWH8BFG9AVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
CARBON DIOXIDEINACTIVE INGREDIENT142M471B3JVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
OXYGENINACTIVE INGREDIENTS88TT14065VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RVARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.]5

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 172 of 173 · 3,458 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc52cb98dc-6858-42bf-9c54-d20fb607dfbb2021-11-12WarningsExact identifier
unii: S88TT14065
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FERRUM PHOSPHORICUM 6XHYDRATED IRON III PHOSPHATESeroyal USA14f4f926-0742-12cd-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: 4J9FJ0HL51
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
OxygenOXYGENAMO Medical Oxygen, Inc.642ebb98-d27f-188b-e053-2a91aa0a0a692020-10-19Exact identifier
unii: S88TT14065
OxygenOXYGENAMO Medical Oxygen, Inc.642ec89f-4ba3-68cd-e053-2991aa0a6a5c2020-10-19Exact identifier
unii: S88TT14065
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OXYGENOXYGENAIRSERVE, LLCf7483c87-439b-4fe2-872e-ebb2b0d5cdbc2019-12-18Exact identifier
unii: S88TT14065
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: S88TT14065
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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