Home NDC 16571-823 Denta 5000 Plus Sensitive
Product NDC 16571-823
11-digit product format 165710823
Labeler code 16571
Product ID 16571-823_3d38b4ec-9283-448f-8fc5-d51cca9de7a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium fluoride and Potassium nitrate
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Rising Pharma Holdings, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-02-14
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength 5.8; 57.5 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Denta 5000 Plus Sensitive
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 5.8 mg/mL POTASSIUM NITRATE 57.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16571-823-10 Denta 5000 Plus Sensitive 100 mL in 1 TUBE GEL, DENTIFRICE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-823 DENTA 5000 PLUS SENSITIVE (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 1 package rows 20240217_585fb1f5-8c08-43bd-8be4-64adc065d9a2.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16571-823-10 16571082310 100 mL in 1 TUBE (16571-823-10) 100 ml 2024-02-14 No No Current