FDA.reportPublic FDA data

Monsels Solution

Manufacturer
Gynex Corporation | Diversified Chemical Products, Inc.
Effective date
2021-10-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:38:09

Label at a glance#

ProductMonsels Solution
Active ingredientFERRIC SUBSULFATE
Label structure5 sections

Storage and handling

Keep cap tightly sealed and away from light. Store at room temperature (15-30°C).

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Ferric Subsulfate...20-22% by weight

INACTIVE INGREDIENT SECTION

Other ingredients include thickeners, preservatives and purified water.

DOSAGE & ADMINISTRATION SECTION

Restricted to use by or on the order of a licensed healthcare professional.

Single-Use only. Do not reuse, discard after one use.

STORAGE AND HANDLING SECTION

Keep cap tightly sealed and away from light.

Store at room temperature (15-30°C).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831162Monsel's ferric subsulfate 20 % - 22 % Topical SolutionPSN2
831162ferric subsulfate solution 220 MG/ML Topical SolutionSCD2
831162Monsel's 20 % - 22 % Topical SolutionSY2
831162Monsel's 20 % Topical SolutionSY2
831162Monsel's 22 % Topical SolutionSY2

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
48992-001-012023-01-30C16284748780-1f386c649-e1f4-0266-e053-dadaa90a7c1a170ce265-2951-47a6-8f56-a27cc39cbdf8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48992-001-01Monsels Solution14 g in 1 VIAL, SINGLE-DOSEPASTE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48992-001MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [GYNEX CORPORATION]2Legacy NDC, 1 package rows20211027_170ce265-2951-47a6-8f56-a27cc39cbdf8.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48992-00148992-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
FERRIC SULFATE3HWS7HF5XDIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
FERRIC SUBSULFATE3QJ8WS6V8HACTIM

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
cf32cbad-332c-2546-e053-2a95a90a5b30170ce265-2951-47a6-8f56-a27cc39cbdf82021-10-25Exact identifier
spl id: cf32cbad-332c-2546-e053-2a95a90a5b30
spl set id: 170ce265-2951-47a6-8f56-a27cc39cbdf8

Reported adverse events (FAERS/openFDA)#

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