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 7 of 11 · 218 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
Methylene BlueMETHYLENE BLUENexus Pharmaceuticals, LLC3484312e-ff43-4425-98e8-cd2ecf9f2a6d2024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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