Arthcal 1% METHYLENE BLUE

Product NDC
85212-0028
11-digit product format
852120028
Labeler code
85212
Product ID
85212-0028_3034e444-15af-660e-e063-6294a90a457e
Type
HUMAN OTC DRUG
Nonproprietary name
METHYLENE BLUE
Dosage form
SOLUTION
Route
EXTRACORPOREAL
Labeler
Beijing JUNGE Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-10
Substance
METHYLENE BLUE
Active strength
1 g/100mL
Pharmacologic classes
Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arthcal 1% METHYLENE BLUE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT42P99266K

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
85212-0028-1Arthcal 1% METHYLENE BLUE50 mL in 1 BOTTLESOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85212-0028ARTHCAL 1% METHYLENE BLUE (METHYLENE BLUE) SOLUTION [BEIJING JUNGE TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250316_3034e444-15ae-660e-e063-6294a90a457e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85212-0028-18521200280150 mL in 1 BOTTLE (85212-0028-1) 50 ml2025-01-10NoNoCurrent