Home NDC 64980-306-50 Denta 5000 Plus
Product NDC 64980-306
Requested package NDC 64980-306-50
11-digit product format 649800306
Labeler code 64980
Product ID 64980-306_a011fc01-64fc-4340-ab2a-21dd884c2ec0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium fluoride
Dosage form GEL, DENTIFRICE
Route ORAL
Labeler Rising Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2012-07-13
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 1 g/100g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64980-306 64980-306-50 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 CARBOXYMETHYLCELLULOSE INACTIVE INGREDIENT 05JZI7B19X DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 POTASSIUM PYROPHOSPHATE INACTIVE INGREDIENT B9W4019H5G DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-306 DENTA 5000 PLUS (SODIUM FLUORIDE) GEL, DENTIFRICE [RISING PHARMA HOLDINGS, INC.] 5 Legacy NDC 20241114_00b09487-043e-4e8c-badd-116dc56eef15.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-306-50 64980030650 2 TUBE in 1 CARTON (64980-306-50) > 51 g in 1 TUBE 2 tube 2012-07-13 0000-00-00 No No Current