FDA.reportPublic FDA data

Ozipco 1% METHYLENE BLUE

Product NDC
86241-003
11-digit product format
862410003
Labeler code
86241
Product ID
86241-003_48e782a9-8a60-2f77-e063-6394a90a31f4
Type
HUMAN OTC DRUG
Nonproprietary name
METHYLENE BLUE
Dosage form
SOLUTION
Route
EXTRACORPOREAL
Labeler
Fast Sold LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ozipco 1% METHYLENE BLUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T42P99266KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248834Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48e789a0-6ee6-c510-e063-6294a90afba0Available on FDA.report

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
86241-003-09Ozipco 1% METHYLENE BLUE50 mL in 1 BOTTLESOLUTION501

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ozipco 1% METHYLENE BLUEMETHYLENE BLUEFast Sold LLC48e789a0-6ee6-c510-e063-6294a90afba02026-01-21WarningsExact identifier
ndc (product): 86241-003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248834methylene blue 1 % Oral SolutionPSN48e789a0-6ee6-c510-e063-6294a90afba01
248834methylene blue 10 MG/ML Oral SolutionSCD48e789a0-6ee6-c510-e063-6294a90afba01
248834methylene blue 1 % Oral SolutionSY48e789a0-6ee6-c510-e063-6294a90afba01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
86241-003-098624100030950 mL in 1 BOTTLE (86241-003-09) 50 ml2025-01-10NoNoCurrent