FLUORIDEX

Product NDC
59883-020
11-digit product format
598830020
Labeler code
59883
Product ID
59883-020_82f8eacb-a214-3080-e053-2a91aa0a6a07
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
2017-01-03
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6014c330-3698-027c-e053-2a91aa0a64e5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-020-04FLUORIDEX1 in 1 BOXPASTE, DENTIFRICE12
59883-020-04FLUORIDEX112 g in 1 TUBEPASTE, DENTIFRICE1122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59883-020-04GM - Gram59883-0209f7114fb-70de-46c1-b219-e278bb27d6dc12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-020FLUORIDEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DEN-MAT HOLDINGS, LLC.]2Current NDC, Legacy NDC, 2 package rows20190301_6014c330-3698-027c-e053-2a91aa0a64e5.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
FLUORIDEXSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.6014c330-3698-027c-e053-2a91aa0a64e52019-02-28Warnings, Adverse reactionsExact identifier
ndc (product): 59883-020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-020-04598830020041 TUBE in 1 BOX (59883-020-04) / 112 g in 1 TUBE1 tube2017-01-030000-00-00NoNoCurrent