FLUORIDEX

Product NDC
59883-016
11-digit product format
598830016
Labeler code
59883
Product ID
59883-016_82f8ac58-f95d-255b-e053-2a91aa0aceb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
DEN-MAT HOLDINGS, LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-12-30
Substance
SODIUM FLUORIDE
Active strength
5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLUORIDEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-016-04FLUORIDEX1 in 1 BOXPASTE, DENTIFRICE12
59883-016-04FLUORIDEX112 g in 1 TUBEPASTE, DENTIFRICE1122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-016FLUORIDEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DEN-MAT HOLDINGS, LLC.]2Current NDC, Legacy NDC, 2 package rows20190301_5fd60635-4b66-15e3-e053-2991aa0ab23a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-016-04598830016041 TUBE in 1 BOX (59883-016-04) / 112 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent