FDA.reportPublic FDA data

MIC B12

Manufacturer
Perdido Key Health and Wellness Inc
Effective date
2015-11-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:21:32

Label at a glance#

ProductMIC B12
Active ingredientINOSITOL, CHOLINE C-11, METHYLCOBALAMIN, L-METHIONINE-S,R-SULFOXIMINE
Label structure2 sections

Label contents#

Full prescribing information#

DOSAGE FORMS & STRENGTHS SECTION

1ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLINE C-11 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1acfa67-deca-4d07-9fa2-83d3856a0e25Product name420180131

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70104-806-012020-01-31C16284748780-19d75b9d0-d729-f424-e053-dadaa90a57ce253ca66e-3c25-0483-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70104-806-01MIC B121 mL in 1 VIALINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70104-806MIC B12 INJECTION [PERDIDO KEY HEALTH AND WELLNESS INC]1Legacy NDC, 1 package rows20151124_253ca66e-3c25-0483-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHOLINE C-11ACTIVE INGREDIENTM4AS4XGD4Q1
INOSITOLACTIVE INGREDIENT4L6452S7491
L-METHIONINE-S,R-SULFOXIMINEACTIVE INGREDIENTM9P6YZ6JX91
METHYLCOBALAMINACTIVE INGREDIENTBR1SN1JS2W1
CHOLINE C-11ACTIVE MOIETYM4AS4XGD4Q1
INOSITOLACTIVE MOIETY4L6452S7491
L-METHIONINE-S,R-SULFOXIMINEACTIVE MOIETYM9P6YZ6JX91
METHYLCOBALAMINACTIVE MOIETYBR1SN1JS2W1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70104-80670104-806-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
INOSITOL4L6452S749ACTIB
CHOLINE C-11M4AS4XGD4QACTIB
METHYLCOBALAMINBR1SN1JS2WACTIB
L-METHIONINE-S,R-SULFOXIMINEM9P6YZ6JX9ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
253ca66e-3c26-0483-e054-00144ff8d46c253ca66e-3c25-0483-e054-00144ff8d46c2015-11-23Exact identifier
spl id: 253ca66e-3c26-0483-e054-00144ff8d46c
spl set id: 253ca66e-3c25-0483-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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