Home NDC 51206-311 Opal by Opalescence Sensitivity
Product NDC 51206-311
11-digit product format 512060311
Labeler code 51206
Product ID 51206-311_5b14ee76-2fcb-639e-e063-6294a90a9211
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate and Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-19
Marketing end 2029-10-15
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.1 mg/g; 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 Opal by Opalescence Sensitivity Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 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 1086243 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51206-311-01 Opal by Opalescence Sensitivity 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-311-01 Opal by Opalescence Sensitivity 133 g in 1 TUBE GEL, DENTIFRICE 133 5 51206-311-02 Opal by Opalescence Sensitivity 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-311-02 Opal by Opalescence Sensitivity 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-311 OPAL BY OPALESCENCE SENSITIVITY (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 4 Current NDC, 4 package rows 20250402_5ffc0d14-0290-47bb-90e5-90a25a5acc28.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 9 of 40 · 786 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 51206-311-01 51206031101 1 TUBE in 1 CARTON (51206-311-01) / 133 g in 1 TUBE 1 tube 2023-11-19 2029-10-15 No No Historical 51206-311-02 51206031102 3 CARTON in 1 PACKAGE, COMBINATION (51206-311-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 3 carton 2023-11-19 2029-10-15 No No Historical