FDA.reportPublic FDA data

NDC 0517-0381-01 - PROVAYBLUE

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
0517-0381
Requested NDC
0517-0381-01
Package NDCs from labels
0517-0381-01, 0517-0381-05
Manufacturer
American Regent, Inc. | Provepharm SAS | Cenexi | CENEXI HSC
Effective date
2025-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROVAYBLUE - American Regent, Inc. | Provepharm SAS | Cenexi | CENEXI HSCAmerican Regent, Inc. | Provepharm SAS | Cenexi | CENEXI HSC2025-05-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0381-01PROVAYBLUE10 mL in 1 VIAL, SINGLE-DOSEINJECTION1028
0517-0381-05PROVAYBLUE5 in 1 CARTONINJECTION528

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0381PROVAYBLUE (METHYLENE BLUE) INJECTION [AMERICAN REGENT, INC.]27Current NDC, Legacy NDC, 2 package rows20241222_4f6848e5-35ed-4046-b13c-3032b5ba3232.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0381-01ML - Milliliter0517-03817a42a7d7-da96-40ac-ba87-46649c5baac612022-04-06
0517-0381-05ML - Milliliter0517-03818c54fb5a-3c9e-4cd0-ad50-f9aa9d2c575a12022-04-06

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 5 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.d820e42d-ad2b-4e11-907b-a94d698ca2852025-08-13Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PROVAYBLUEMETHYLENE BLUEAmerican Regent, Inc.4f6848e5-35ed-4046-b13c-3032b5ba32322025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA204630
ndc (package): 0517-0125-01
ndc (package): 0517-0374-05
ndc (package): 0517-0371-05
ndc (package): 0517-0381-01
ndc (package): 0517-0374-01
ndc (package): 0517-0381-05
ndc (package): 0517-0125-05
ndc (package): 0517-0371-01
ndc (product): 0517-0374
ndc (product): 0517-0371
ndc (product): 0517-0381
ndc (product): 0517-0125
ndc11 (package): 00517038101
rxcui: 1788989
rxcui: 2199323
rxcui: 1788984
rxcui: 2199324
spl id: 420bd985-ac55-44b9-b8a0-a5098220575b
spl set id: 4f6848e5-35ed-4046-b13c-3032b5ba3232
unii: T42P99266K
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
CelltemCARBO VEGETABILIS, ANILINUM, RADIUM BROMATUM, MILLEFOLIUM, MEDULLA OSSIS SUIS, RNA, DNA, METHYLENE BLUE, ABROTANUM, CALCAREA OXALICA, CONIUM MACULATUM, EUPHORBIA COROLLATA, EUPHORBIUM OFFICINARUMNucleic Products, LLCcd6670f1-d910-4228-ad8c-0bbe173e3a8c2025-03-20WarningsExact identifier
unii: T42P99266K
Arthcal 1% METHYLENE BLUEMETHYLENE BLUEBeijing JUNGE Technology Co., Ltd.3034e444-15ae-660e-e063-6294a90a457e2025-03-13WarningsExact identifier
unii: T42P99266K
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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