FDA.reportPublic FDA data

Methylene Blue

Manufacturer
KDG Impresa LLC, Aqion
Effective date
2023-12-07
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:58

Label at a glance#

ProductMethylene Blue
Active ingredientMETHYLENE BLUE
Label structure1 sections

Label contents#

Full prescribing information#

Methylene Blue Bulk Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methylene Blue Bulk Label
Methylene Blue Bulk Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43457-653-25Methylene Blue25 kg in 1 DRUMCRYSTAL251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43457-653METHYLENE BLUE CRYSTAL [KDG IMPRESA LLC, AQION]11 package rows20231208_0ed947bd-72ca-4eea-a8c9-cba63c291ce9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43457-65343457-653-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLENE BLUET42P99266KACTIM

Source Document#

Source XML

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 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLENE BLUEMETHYLENE BLUEXIROMED, LLC691a6872-bc2f-d492-11c6-c3eec25aa3d32026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLENE BLUE
generic name: METHYLENE BLUE
METHYLENE BLUEMETHYLENE BLUEGLENMARK PHARMACEUTICALS INC., USAeec9bc86-b15b-4c0c-a669-65b03b73da0b2026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLENE BLUE
generic name: METHYLENE BLUE
Methylene blueMETHYLENE BLUEZydus Lifesciences Limiteddf3568d6-d509-4c93-9a92-0e3d1d8514dc2026-04-02Name fallback
brand name: Methylene blue
generic name: METHYLENE BLUE
Methylene blueMETHYLENE BLUEZydus Pharmaceuticals USA Inc.8c56fbad-a449-4ed4-a55f-1694e4e8e26a2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene blue
generic name: METHYLENE BLUE
Methylene BlueMETHYLENE BLUEOLIC (Thailand) Limitedd115faab-577f-4299-87ed-8d4f909b46592026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene Blue
generic name: METHYLENE BLUE
Methylene BlueMETHYLENE BLUEBPI LABS LLCe2d9d96c-a711-47c5-855a-7eb7f163493e2026-03-11Boxed warning, WarningsName fallback
brand name: Methylene Blue
generic name: METHYLENE BLUE
Methylene blueMETHYLENE BLUEHikma Pharmaceuticals USA Inc.4f222ee5-df03-46d5-a060-c63565b7186f2026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene blue
generic name: METHYLENE BLUE
METHYLENE BLUEMETHYLENE BLUEChengdu Shuode Pharmaceutical Co., Ltdfe47491d-810e-466a-aab2-aa92756492ba2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLENE BLUE
generic name: METHYLENE BLUE
Ozipco 1% METHYLENE BLUEMETHYLENE BLUEFast Sold LLC48e789a0-6ee6-c510-e063-6294a90afba02026-01-21WarningsName fallback
generic name: METHYLENE BLUE
Methylene blueMETHYLENE BLUESteriscience Specialties Private Limitedeb87d31c-3a8e-4089-9693-20bc172796502026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene blue
generic name: METHYLENE BLUE
Methylene BlueMETHYLENE BLUEBPI LABS LLCfbdd583d-45ba-4d42-8c80-9a13b71980b62025-12-26Boxed warning, WarningsName fallback
brand name: Methylene Blue
generic name: METHYLENE BLUE
Methylene blueMETHYLENE BLUEAmneal Pharmaceuticals LLC67da2a69-8166-46c7-921c-d6ec47bfeac82025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene blue
generic name: METHYLENE BLUE
PROVAYBLUEMETHYLENE BLUEAmerican Regent, Inc.4f6848e5-35ed-4046-b13c-3032b5ba32322025-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLENE BLUE
Arthcal 1% METHYLENE BLUEMETHYLENE BLUEBeijing JUNGE Technology Co., Ltd.3034e444-15ae-660e-e063-6294a90a457e2025-03-13WarningsName fallback
generic name: METHYLENE BLUE
Methylene BlueMETHYLENE BLUEMeitheal Pharmaceuticals Inc.2566ce72-9d19-42e5-80f9-8fc4612b1eff2025-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene Blue
generic name: METHYLENE BLUE
Methylene BlueMETHYLENE BLUENexus Pharmaceuticals, LLC3484312e-ff43-4425-98e8-cd2ecf9f2a6d2024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylene Blue
generic name: METHYLENE BLUE

Reported adverse events (FAERS/openFDA)#

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