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 Identifiers#

Field, Values table
FieldValues
Unii3QJ8WS6V8H
Rxcui831162

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

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