FDA.reportPublic FDA data

Monsels solution

Manufacturer
BIODIAGNOSTIC INTERNATIONAL | International Bio Diagnostic
Effective date
2018-03-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:25:28

Label at a glance#

ProductMonsels solution
Active ingredientFERRIC SUBSULFATE
Label structure6 sections

Storage and handling

Store at (15-30C)

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Ferric Sub sulfate 20%

STORAGE AND HANDLING SECTION

Store at (15-30C)

HOW SUPPLIED SECTION

Contents 12 single application vials
12 rayon tip applicators

INDICATIONS & USAGE SECTION

Used as a styptic in its undiluted form.

PRECAUTIONS SECTION

To be used by a lic. Medical practitioner only.

Uni dose. Discard after single use.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831162Monsel's ferric subsulfate 20 % - 22 % Topical SolutionPSN3
831162ferric subsulfate solution 220 MG/ML Topical SolutionSCD3
831162Monsel's 20 % - 22 % Topical SolutionSY3
831162Monsel's 20 % Topical SolutionSY3
831162Monsel's 22 % Topical SolutionSY3

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
42721-112-082020-01-31C16284748780-19d75b9d0-69fd-f424-e053-dadaa90a57ceMonsel's solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42721-112-08Monsels solution12 in 1 BOXLIQUID123
42721-112-08Monsels solution8 g in 1 VIALLIQUID83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42721-112MONSELS SOLUTION (FERRIC SUB SULFATE 20%) LIQUID [BIODIAGNOSTIC INTERNATIONAL]3Legacy NDC, 2 package rows20180301_dd55392c-80a9-47d4-9079-408e30065aa1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC SUBSULFATEACTIVE INGREDIENT3QJ8WS6V8H2
FERRIC CATIONACTIVE MOIETY91O4LML6112
WATERINACTIVE INGREDIENT059QF0KO0R2

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
42721-11242721-112-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC SUBSULFATE3QJ8WS6V8HACTIM
WATER059QF0KO0RIACT

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
ae51923c-0d30-4d63-9bdd-5e2acb8ff0fcdd55392c-80a9-47d4-9079-408e30065aa12018-03-01Exact identifier
spl id: ae51923c-0d30-4d63-9bdd-5e2acb8ff0fc
spl set id: dd55392c-80a9-47d4-9079-408e30065aa1

Reported adverse events (FAERS/openFDA)#

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