Home NDC 85212-0028 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 Ingredient Strength METHYLENE BLUE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T42P99266K Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85212-0028-1 Arthcal 1% METHYLENE BLUE 50 mL in 1 BOTTLE SOLUTION 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85212-0028 ARTHCAL 1% METHYLENE BLUE (METHYLENE BLUE) SOLUTION [BEIJING JUNGE TECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20250316_3034e444-15ae-660e-e063-6294a90a457e.zip
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85212-0028-1 85212002801 50 mL in 1 BOTTLE (85212-0028-1) 50 ml 2025-01-10 No No Current