Home NDC 66975-720 PRO-SYS
Product NDC 66975-720
11-digit product format 669750720
Labeler code 66975
Product ID 66975-720_4e53a23c-7977-632d-e063-6394a90a7ae6
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL; ORAL
Labeler Benco Dental
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance SODIUM FLUORIDE
Active strength .11 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 PRO-SYS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .11 g/100g
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 416783 Internal RxNorm 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 66975-720-01 PRO-SYS 113.4 g in 1 TUBE PASTE, DENTIFRICE 113.4 1 66975-720-02 PRO-SYS 24 g in 1 TUBE PASTE, DENTIFRICE 24 1
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 34 of 51 · 1,013 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66975-720-01 66975072001 113.4 g in 1 TUBE (66975-720-01) 113.4 g 2025-12-01 No No Current 66975-720-02 66975072002 24 g in 1 TUBE (66975-720-02) 24 g 2025-12-01 No No Current