Home NDC 51206-314 Opalescence Whitening
Product NDC 51206-314
11-digit product format 512060314
Labeler code 51206
Product ID 51206-314_5b14bdd2-2852-1c00-e063-6294a90ac4cc
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-23
Marketing end 2031-01-31
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
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 Opalescence Whitening
Brand name suffix Cool Mint 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 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 51206-314-01 Opalescence WhiteningCool Mint 133 g in 1 TUBE GEL, DENTIFRICE 133 3 51206-314-01 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-02 Opalescence WhiteningCool Mint 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 3 51206-314-02 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-03 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-03 Opalescence WhiteningCool Mint 28 g in 1 TUBE GEL, DENTIFRICE 28 3 51206-314-04 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-04 Opalescence WhiteningCool Mint 24 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 24 3 51206-314-05 Opalescence WhiteningCool Mint 48 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 48 3 51206-314-05 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3
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 35 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 51206-314-01 51206031401 1 TUBE in 1 CARTON (51206-314-01) / 133 g in 1 TUBE 1 tube 2025-09-23 2031-01-31 No No Historical 51206-314-02 51206031402 12 CARTON in 1 PACKAGE, COMBINATION (51206-314-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 12 carton 2025-09-23 2031-01-30 No No Historical 51206-314-03 51206031403 1 TUBE in 1 CARTON (51206-314-03) / 28 g in 1 TUBE 1 tube 2025-09-23 2030-11-30 No No Historical 51206-314-04 51206031404 24 CARTON in 1 PACKAGE, COMBINATION (51206-314-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE 24 carton 2025-09-23 2030-11-30 No No Historical 51206-314-05 51206031405 48 CARTON in 1 PACKAGE, COMBINATION (51206-314-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE 48 carton 2025-09-23 2030-10-31 No No Historical