FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562510Internal RxNorm lookup
1488074Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e39b19f7-2b3e-4c77-9544-623ebad84870Available on FDA.report

DailyMed Package Descriptions#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PRO-DEN RX (SODIUM FLUORIDE) RINSE [ZILA THERAPEUTICS, INC.]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OPRO-DEN RX (SODIUM FLUORIDE) RINSE [ZILA THERAPEUTICS, INC.]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPRO-DEN RX (SODIUM FLUORIDE) RINSE [ZILA THERAPEUTICS, INC.]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PRO-DEN RX (SODIUM FLUORIDE) RINSE [ZILA THERAPEUTICS, INC.]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PRO-DEN RX (SODIUM FLUORIDE) RINSE [ZILA THERAPEUTICS, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RPRO-DEN RX (SODIUM FLUORIDE) RINSE [ZILA THERAPEUTICS, INC.]5

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

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
Pro-Den RxSODIUM FLUORIDEDen-mat Holdings, Llce39b19f7-2b3e-4c77-9544-623ebad848702019-02-28Warnings, Adverse reactionsExact identifier
ndc (product): 59883-920

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