Pro-Den Rx

Product NDC
59883-824
11-digit product format
598830824
Labeler code
59883
Product ID
59883-824_82f925fe-19ca-720a-e053-2a91aa0a9b27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
ORAL
Labeler
Den-mat Holdings, Llc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-01-20
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
4 g/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OPRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]3
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RPRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-824PRO-DEN RX (SODIUM FLUORIDE) GEL [DEN-MAT HOLDINGS, LLC]5Legacy NDC20190301_7ac93812-7813-40a2-9f8f-9926a6e92cf9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-824-02598830824021 TUBE in 1 CARTON (59883-824-02) > 56 g in 1 TUBE1 tube2009-01-200000-00-00NoNoCurrent