FDA.reportPublic FDA data

NDC 54288-159-01 - Methylene Blue

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
54288-159
Requested NDC
54288-159-01
Package NDCs from labels
54288-159-01, 54288-159-05
Manufacturer
BPI LABS LLC
Effective date
2025-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylene Blue - BPI LABS LLCBPI LABS LLC2025-12-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54288-159-052025-02-11C16284748780-12cef2736-7566-d83d-e063-dadaa90ab31fMethylene Blue Injection, USP 1%
54288-159-052025-01-30C16284748780-12cef2736-7566-d83d-e063-dadaa90ab31fMethylene Blue Injection, USP 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-159-01Methylene Blue2 mL in 1 SYRINGEINJECTION25
54288-159-05Methylene Blue5 in 1 PACKAGEINJECTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-159METHYLENE BLUE INJECTION [BPI LABS LLC]3Current NDC, 2 package rows20250213_fbdd583d-45ba-4d42-8c80-9a13b71980b6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-159-01ML - Milliliter54288-159482829ce-5c1c-49f7-9ad9-8fb1377a90e812024-01-04
54288-159-05ML - Milliliter54288-159c182b316-2272-4724-a1a9-5942b6fe783912024-01-04

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 6 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Methylene BlueMETHYLENE BLUEMeitheal Pharmaceuticals Inc.2566ce72-9d19-42e5-80f9-8fc4612b1eff2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
URIMAR-T CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLCcf7c3d65-11d2-49cd-b207-8ccc6a221fe02025-01-08Warnings, Adverse reactionsExact identifier
unii: T42P99266K

Reported adverse events (FAERS/openFDA)#

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