FDA.reportPublic FDA data

Monsels Solution

Manufacturer
Premier Dental Products Company | Diversified Chemical Products Inc
Effective date
2026-01-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:55:14

Label at a glance#

ProductMonsels Solution
Active ingredientFERRIC SUBSULFATE
Label structure5 sections

Storage and handling

Store at room temperature (15-30°C). Keep cap tightly sealed. Protect from light. Mfg. for and Dist. by: Premier Medical Products Plymouth Meeting, PA 19462

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

Do not reuse, discard after one use.

STORAGE AND HANDLING SECTION

Store at room temperature (15-30°C).

Keep cap tightly sealed.

Protect from light.

Mfg. for and Dist. by:

Premier Medical Products

Plymouth Meeting, PA 19462

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Contains 8ml NDC 48783-112-08

Premier

Monsel's Ferric Subsulfate Solution

REF 9045055

12 single application 8ml bottles of Monsel's soution

and 12 rayon tip applicators

Rx ONLY Made in U.S.A. PremierMonselsPremierMonsels

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
48783-112-082023-03-20C16284748780-1f386c64a-36f9-0266-e053-dadaa90a7c1aMonsels
48783-112-082023-01-30C16284748780-1f386c64a-36f9-0266-e053-dadaa90a7c1aMonsels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48783-112-08Monsels Solution14 g in 1 VIAL, SINGLE-DOSEPASTE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48783-112-08ML - Milliliter48783-1125ec8b1de-6879-4f31-9f04-5ee4f50698e412018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC SUBSULFATEACTIVE INGREDIENT3QJ8WS6V8H1
FERRIC CATIONACTIVE MOIETY91O4LML6111
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
FERRIC SULFATEINACTIVE INGREDIENT3HWS7HF5XD1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
48783-11248783-112-08

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+dosage form
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+dosage form
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+dosage form
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+dosage form
14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates

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
Monsels SolutionFERRIC SUBSULFATEPremier Dental Products Company7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db2026-01-13Exact identifier
ndc (package): 48783-112-08
ndc (product): 48783-112
ndc11 (package): 48783011208
spl id: 4847c0c4-f60a-2f71-e063-6294a90a5830
spl set id: 7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db

Reported adverse events (FAERS/openFDA)#

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