Home NDC 59883-911 Pro-Den Rx
Product NDC 59883-911
11-digit product format 598830911
Labeler code 59883
Product ID 59883-911_6a0ff4f9-a7f9-1e75-e053-2991aa0a2782
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 Ingredient Strength SODIUM FLUORIDE 9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59883-911-64 Pro-Den Rx 1890 mL in 1 BOTTLE, PLASTIC RINSE 1890 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59883-911 PRO-DEN RX (SODIUM FLUORIDE) RINSE [DEN-MAT HOLDINGS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20180420_ba020e07-ad41-4419-a503-f1245131b7d2.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 Marketing end Sample Exclude flag Status 59883-911-64 59883091164 1890 mL in 1 BOTTLE, PLASTIC (59883-911-64) 1890 ml 2008-10-21 0000-00-00 No No Current