Pro-Den Rx

Product NDC
59883-920
11-digit product format
598830920
Labeler code
59883
Product ID
59883-920_82f8dd55-36df-0de0-e053-2991aa0a6bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Den-mat Holdings, Llc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-10-21
Substance
SODIUM FLUORIDE
Active strength
.9 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pro-Den Rx
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui562510, 1488074

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-920-16Pro-Den Rx473 mL in 1 BOTTLE, PLASTICRINSE4737

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-920PRO-DEN RX (SODIUM FLUORIDE) RINSE [DEN-MAT HOLDINGS, LLC]7Current NDC, Legacy NDC, 1 package rows20190301_e39b19f7-2b3e-4c77-9544-623ebad84870.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488074Pro-Den Rx 0.2 % (fluoride ion 0.9 % ) Oral RinsePSNe39b19f7-2b3e-4c77-9544-623ebad848707
562510sodium fluoride 0.2 % Oral RinsePSNe39b19f7-2b3e-4c77-9544-623ebad848707
1488074sodium fluoride 2 MG/ML Mouthwash [ProDenRx Rinse]SBDe39b19f7-2b3e-4c77-9544-623ebad848707
562510sodium fluoride 2 MG/ML MouthwashSCDe39b19f7-2b3e-4c77-9544-623ebad848707
1488074ProDenRx Rinse 0.2 % Oral RinseSYe39b19f7-2b3e-4c77-9544-623ebad848707
1488074ProDenRx Rinse 2 MG/ML MouthwashSYe39b19f7-2b3e-4c77-9544-623ebad848707
562510sodium fluoride 0.2 % MouthwashSYe39b19f7-2b3e-4c77-9544-623ebad848707

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-920-1659883092016473 mL in 1 BOTTLE, PLASTIC (59883-920-16) 473 ml2008-10-210000-00-00NoNoCurrent