FDA.reportPublic FDA data

MONSEL

Manufacturer
PURTEX INC | US SPECIALTY FORMULATIONS LLC
Effective date
2019-11-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:30:19

Label at a glance#

ProductMONSEL
Active ingredientFERRIC SUBSULFATE
Label structure2 sections

Label contents#

Full prescribing information#

BOXED WARNING SECTION

Monsel SolutionMonsel Solution

Monsel Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Monsel Ferric SubsulfateMonsel Ferric Subsulfate

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FERRIC CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70804-112-082022-01-28C16284748780-1d6a99b39-d281-a426-e053-dadaa90af4c2Restricted to use by or on the order of a licensed Physician. Keep cap tightly sealed and protect from light

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70804-112-08MONSEL1 in 1 VIALPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70804-112MONSEL (FERRIC, SUBSULTATE) PASTE [PURTEX INC]2Legacy NDC, 1 package rows20191112_42b09a53-7f5c-461b-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70804-11270804-112-08

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
FERRIC SUBSULFATE3QJ8WS6V8HACTIM

Source Document#

Source XML · Source PDF

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
971515fa-b4d4-1197-e053-2995a90a838d42b09a53-7f5c-461b-e054-00144ff88e882019-11-11Boxed warningExact identifier
spl id: 971515fa-b4d4-1197-e053-2995a90a838d
spl set id: 42b09a53-7f5c-461b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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