Home NDC 70683-0703 Dentisse
Product NDC 70683-0703
11-digit product format 706830703
Labeler code 70683
Product ID 70683-0703_42c83cbe-24d7-6ccb-e063-6294a90ab55b
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL; ORAL
Labeler Dentisse, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-02-13
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
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 Dentisse
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 Internal RxNorm 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 70683-0703-2 Dentisse 91 g in 1 TUBE PASTE, DENTIFRICE 91 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70683-0703 DENTISSE (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTISSE, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231220_326b290a-9bd2-468e-e054-00144ff8d46c.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 5 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70683-0703-2 70683070302 91 g in 1 TUBE (70683-0703-2) 91 g 2014-02-13 0000-00-00 No No Current