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 2 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
METHYLENE BLUEMETHYLENE BLUEXIROMED, LLC691a6872-bc2f-d492-11c6-c3eec25aa3d32026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
METHYLENE BLUEMETHYLENE BLUEGLENMARK PHARMACEUTICALS INC., USAeec9bc86-b15b-4c0c-a669-65b03b73da0b2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Methylene blueMETHYLENE BLUEZydus Lifesciences Limiteddf3568d6-d509-4c93-9a92-0e3d1d8514dc2026-04-02Exact identifier
rxcui: 2199323
rxcui: 1788984
unii: T42P99266K
Methylene blueMETHYLENE BLUEZydus Pharmaceuticals USA Inc.8c56fbad-a449-4ed4-a55f-1694e4e8e26a2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2199323
rxcui: 1788984
unii: T42P99266K
Methylene BlueMETHYLENE BLUEOLIC (Thailand) Limitedd115faab-577f-4299-87ed-8d4f909b46592026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Methylene BlueMETHYLENE BLUEBPI LABS LLCe2d9d96c-a711-47c5-855a-7eb7f163493e2026-03-11Boxed warning, WarningsExact identifier
unii: T42P99266K
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.f650dd78-615c-42d3-9b2d-3a989039d80c2026-03-05Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Methylene blueMETHYLENE BLUEHikma Pharmaceuticals USA Inc.4f222ee5-df03-46d5-a060-c63565b7186f2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
METHYLENE BLUEMETHYLENE BLUEChengdu Shuode Pharmaceutical Co., Ltdfe47491d-810e-466a-aab2-aa92756492ba2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
Ozipco 1% METHYLENE BLUEMETHYLENE BLUEFast Sold LLC48e789a0-6ee6-c510-e063-6294a90afba02026-01-21WarningsExact identifier
unii: T42P99266K
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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