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 Identifiers#

Field, Values table
FieldValues
Unii3QJ8WS6V8H

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#

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

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