FDA.reportPublic FDA data

Monsels Solution

Product NDC
48783-113
11-digit product format
487830113
Labeler code
48783
Product ID
48783-113_4847bf58-c079-1cfd-e063-6294a90ab69b
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
2024-11-29
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
831162Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26408e81-f131-15ca-e063-6394a90a6fb6Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48783-113-08Monsels Solution14 g in 1 VIAL, SINGLE-DOSEPASTE144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48783-113-08ML - Milliliter48783-1132f4aa1dc-142c-4140-8355-733883e9bf0512025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48783-113MONSELS SOLUTION (FERRIC SUBSULFATE) PASTE [PREMIER DENTAL PRODUCTS COMPANY]3Current NDC, 1 package rows20250330_26408e81-f131-15ca-e063-6394a90a6fb6.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 Company26408e81-f131-15ca-e063-6394a90a6fb62026-01-13Exact identifier
ndc (product): 48783-113

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831162Monsel's ferric subsulfate 20 % - 22 % Topical SolutionPSN26408e81-f131-15ca-e063-6394a90a6fb64
831162ferric subsulfate solution 220 MG/ML Topical SolutionSCD26408e81-f131-15ca-e063-6394a90a6fb64
831162Monsel's 20 % - 22 % Topical SolutionSY26408e81-f131-15ca-e063-6394a90a6fb64
831162Monsel's 20 % Topical SolutionSY26408e81-f131-15ca-e063-6394a90a6fb64
831162Monsel's 22 % Topical SolutionSY26408e81-f131-15ca-e063-6394a90a6fb64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48783-113-084878301130814 g in 1 VIAL, SINGLE-DOSE (48783-113-08) 14 g2024-11-29NoNoCurrent