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 2 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-KIDNEYCHONDRODENDRON TOMENTOSUM ROOT - CLERODENDRANTHUS SPICATUS LEAF - EQUISETUM HYEMALE - ESCHERICHIA COLI - HIERACIUM PILOSELLA FLOWERING TOP - METHYLENE BLUE - NITRIC ACID - ONONIS CAMPESTRIS - PLANTAGO MAJOR - PORK KIDNEY - POTASSIUM NITRATE - PROTEUS VULGARIS - QUINHYDRONE - SARSAPARILLA - SOLIDAGO VIRGAUREA FLOWERING TOP - SUCCINIC ACID - SUS SCROFA URETER - SUS SCROFA URINARY BLADDER -Guna spa45c3c1af-e2b4-4239-98d9-f675c0e7d3222026-06-11WarningsExact identifier
unii: T42P99266K
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
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
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
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
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
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
unii: T42P99266K
Methylene blueMETHYLENE BLUEZydus Pharmaceuticals USA Inc.8c56fbad-a449-4ed4-a55f-1694e4e8e26a2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Methylene BlueMETHYLENE BLUEOLIC (Thailand) Limitedd115faab-577f-4299-87ed-8d4f909b46592026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
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
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
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

Reported adverse events (FAERS/openFDA)#

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