FDA.reportPublic FDA data

FLUORIDEX

Product NDC
59883-031
11-digit product format
598830031
Labeler code
59883
Product ID
59883-031_2cf0556f-5090-c02c-e063-6394a90a4b40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
DENT-MAT HOLDINGS, LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-12-21
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 5 mg/g; 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
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637365Internal RxNorm lookup
847014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
601774d5-f4de-01bc-e053-2991aa0a7f4fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-031-04FLUORIDEX1 in 1 BOXPASTE, DENTIFRICE15
59883-031-04FLUORIDEX112 g in 1 TUBEPASTE, DENTIFRICE1125
59883-031-05FLUORIDEX24 g in 1 TUBEPASTE, DENTIFRICE245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59883-031-04GM - Gram59883-03117c3cf8a-6ab2-46e3-8ada-10998a1c952212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-031FLUORIDEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENT-MAT HOLDINGS, LLC.]5Current NDC, Legacy NDC, 3 package rows20250131_601774d5-f4de-01bc-e053-2991aa0a7f4f.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 FLUORIDEDENT-MAT HOLDINGS, LLC.601774d5-f4de-01bc-e053-2991aa0a7f4f2025-01-30Warnings, Adverse reactionsExact identifier
ndc (product): 59883-031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847014Fluoridex Daily Defense Sensitivity 5 % / 1.1 % ToothpastePSN601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SBD601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014Fluoridex Daily Defense Sensitivity (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014Fluoridex Daily Defense Sensitivity ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SY601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SY601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-031-04598830031041 TUBE in 1 BOX (59883-031-04) / 112 g in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent
59883-031-055988300310524 g in 1 TUBE (59883-031-05) 24 g2018-08-220000-00-00YesNoCurrent