Home NDC 51206-308 Opalescence Sensitivity Relief Whitening
Product NDC 51206-308
11-digit product format 512060308
Labeler code 51206
Product ID 51206-308_5b14ddfe-ec8e-3a25-e063-6294a90afe5b
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 2015-11-30
Marketing end 2030-10-13
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 Opalescence Sensitivity Relief Whitening 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 51206-308-01 Opalescence Sensitivity Relief Whitening 28.35 g in 1 TUBE GEL, DENTIFRICE 28.35 11 51206-308-01 Opalescence Sensitivity Relief Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 11 51206-308-02 Opalescence Sensitivity Relief Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 11 51206-308-02 Opalescence Sensitivity Relief Whitening 133 g in 1 TUBE GEL, DENTIFRICE 133 11 51206-308-03 Opalescence Sensitivity Relief Whitening 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 11 51206-308-03 Opalescence Sensitivity Relief Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 11 51206-308-04 Opalescence Sensitivity Relief Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 11 51206-308-04 Opalescence Sensitivity Relief Whitening 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 11 51206-308-05 Opalescence Sensitivity Relief Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 11 51206-308-05 Opalescence Sensitivity Relief Whitening 24 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 24 11 51206-308-06 Opalescence Sensitivity Relief Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 11 51206-308-06 Opalescence Sensitivity Relief Whitening 6 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 6 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Potassium Nitrate ACTIVE INGREDIENT RU45X2JN0Z OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Fluoride ACTIVE INGREDIENT 8ZYQ1474W7 OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Fluoride Ion ACTIVE MOIETY Q80VPU408O OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Nitrate Ion ACTIVE MOIETY T93E9Y2844 OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Methyl Salicylate INACTIVE INGREDIENT LAV5U5022Y OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Xylitol INACTIVE INGREDIENT VCQ006KQ1E OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-308 OPALESCENCE SENSITIVITY RELIEF WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 9 Current NDC, Legacy NDC, 12 package rows 20240224_b5176a84-76a3-4ad0-a2e2-4997a12da9a5.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 14 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 51206-308-01 51206030801 1 TUBE in 1 CARTON (51206-308-01) / 28.35 g in 1 TUBE 1 tube 2015-11-30 2030-10-13 No No Current 51206-308-02 51206030802 1 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE 1 tube 2015-11-30 2030-10-13 No No Current 51206-308-03 51206030803 3 CARTON in 1 PACKAGE, COMBINATION (51206-308-03) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 3 carton 2015-11-30 2030-10-13 No No Current 51206-308-04 51206030804 12 CARTON in 1 PACKAGE, COMBINATION (51206-308-04) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 12 carton 2015-11-30 2030-10-13 No No Current 51206-308-05 51206030805 24 CARTON in 1 PACKAGE, COMBINATION (51206-308-05) / 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE 24 carton 2015-11-30 2030-10-13 No No Current 51206-308-06 51206030806 6 CARTON in 1 PACKAGE, COMBINATION (51206-308-06) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 6 carton 2015-11-30 2030-10-13 No No Current