FDA.reportPublic FDA data

Monsels Solution

Product NDC
48783-112
11-digit product format
487830112
Labeler code
48783
Product ID
48783-112_4847c0c4-f60a-2f71-e063-6294a90a5830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferric Subsulfate
Dosage form
PASTE
Route
TOPICAL
Labeler
Premier Dental Products Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-06-10
Substance
FERRIC SUBSULFATE
Active strength
210 mg/g
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Monsels Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC SUBSULFATE210 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3QJ8WS6V8HInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a9923af-b8ed-4dc5-b6ae-2f42f83eb3dbAvailable on FDA.report

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC SUBSULFATEACTIVE INGREDIENT3QJ8WS6V8HMONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]1
FERRIC CATIONACTIVE MOIETY91O4LML611MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]1
FERRIC SULFATEINACTIVE INGREDIENT3HWS7HF5XDMONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RMONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48783-112MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]7Current NDC, Legacy NDC, 1 package rows20241027_7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db.zip

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 (product): 48783-112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48783-112-084878301120814 g in 1 VIAL, SINGLE-DOSE (48783-112-08) 14 g2014-06-100000-00-00NoNoCurrent