Home NDC 51206-315 Opalescence Whitening Sensitivity Relief
Product NDC 51206-315
11-digit product format 512060315
Labeler code 51206
Product ID 51206-315_5b14ca86-96a0-7c20-e063-6394a90af5bd
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 2025-10-08
Marketing end 2030-12-31
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength 1.1; 50 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 Whitening Sensitivity Relief Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g POTASSIUM NITRATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 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 51206-315-01 Opalescence Whitening Sensitivity Relief 1 in 1 CARTON GEL, DENTIFRICE 1 2 51206-315-01 Opalescence Whitening Sensitivity Relief 133 g in 1 TUBE GEL, DENTIFRICE 133 2 51206-315-02 Opalescence Whitening Sensitivity Relief 1 in 1 CARTON GEL, DENTIFRICE 1 2 51206-315-02 Opalescence Whitening Sensitivity Relief 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 2 51206-315-03 Opalescence Whitening Sensitivity Relief 28 g in 1 TUBE GEL, DENTIFRICE 28 2 51206-315-03 Opalescence Whitening Sensitivity Relief 1 in 1 CARTON GEL, DENTIFRICE 1 2 51206-315-04 Opalescence Whitening Sensitivity Relief 1 in 1 CARTON GEL, DENTIFRICE 1 2 51206-315-04 Opalescence Whitening Sensitivity Relief 24 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 24 2 51206-315-05 Opalescence Whitening Sensitivity Relief 1 in 1 CARTON GEL, DENTIFRICE 1 2 51206-315-05 Opalescence Whitening Sensitivity Relief 48 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 48 2
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 16 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GuruNanda Oxyfusion HYDROGEN PEROXIDE GURUNANDA, LLC 3be317b9-a5d8-b198-e063-6394a90af985 2025-11-11 Warnings Exact identifier application number: M022 GuruNanda Oral Pain Relief MENTHOL GURUNANDA, LLC 3b8f3562-0e46-bea4-e063-6294a90adb71 2025-11-11 Warnings Exact identifier application number: M022 TopCare Cherry Flavor PHENOL TOPCO ASSOCIATES, LLC 5d3f0610-deb4-4180-ae19-2c65ed2f368b 2025-11-10 Warnings Exact identifier application number: M022 Topcare Sore Throat Menthol Flavor PHENOL TOPCO ASSOCIATES LLC fb1f2c11-2508-4985-bae5-7d547bd6aa23 2025-11-10 Warnings Exact identifier application number: M022 Zilactin-B BENZOCAINE ASCENT CONSUMER PRODUCTS, INC 42eeb3d4-bac6-4e29-e063-6294a90a644d 2025-11-06 Warnings Exact identifier application number: M022 Zilactin Early Relief Cold Sore BENZYL ALCOHOL ASCENT CONSUMER PRODUCTS, INC 42ef8bfa-c4d9-01cf-e063-6394a90ac88a 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 106b6115-d043-4050-80c6-1d82456dea02 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 4c278122-2643-46bf-9e44-11985210a16e 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC fee9969d-ad1a-4f44-9741-a0a44c9e1128 2025-11-06 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE Target Corporation 0ddf9945-147d-4b25-98a6-4e9f12a4656f 2025-11-05 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. e6a312e5-17ac-46f0-8723-4e40eeecd69f 2025-11-04 Warnings Exact identifier application number: M022 PEROXY SHIELD MOUTH SORE 1.5% HYDROGEN PEROXIDE Dental Technologies, Inc. a72e433b-1b7d-4a0c-e053-2995a90a30c4 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ae628766-25b7-4b4f-abb8-a43faf2f44b9 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. 719743f9-21fc-4568-b879-acdfa4639464 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ff0695a1-1d7d-4b51-97fd-689e56d914fe 2025-11-04 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Family Dollar (FAMILY WELLNESS) f7edf75c-cdba-4dde-bfc5-a04af34759d3 2025-11-03 Warnings Exact identifier application number: M022 7 Select Oral Pain Maximum Strength Relief BENZOCAINE 7-ELEVEN, INC. f170a570-1c50-4b9a-be16-9b01bf5eaa74 2025-10-31 Warnings Exact identifier application number: M022 Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE Universal Distribution Center LLC 18520f9b-4d35-1e9c-e063-6294a90aaa39 2025-10-30 Warnings Exact identifier application number: M022 Iodent Oral Analgesic BENZOCAINE United Exchange Corp. 63902125-f8dc-0ada-e053-2991aa0a7ce5 2025-10-30 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE BETTER LIVING BRANDS, LLC 3bded237-4d2c-4b38-bedc-267fdc374194 2025-10-29 Warnings Exact identifier application number: M022
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 51206-315-01 51206031501 1 TUBE in 1 CARTON (51206-315-01) / 133 g in 1 TUBE 1 tube 2025-10-08 2030-12-31 No No Historical 51206-315-02 51206031502 12 CARTON in 1 PACKAGE, COMBINATION (51206-315-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 12 carton 2025-10-08 2030-12-31 No No Historical 51206-315-03 51206031503 1 TUBE in 1 CARTON (51206-315-03) / 28 g in 1 TUBE 1 tube 2025-10-08 2030-12-31 No No Historical 51206-315-04 51206031504 24 CARTON in 1 PACKAGE, COMBINATION (51206-315-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE 24 carton 2025-10-08 2030-12-31 No No Historical 51206-315-05 51206031505 48 CARTON in 1 PACKAGE, COMBINATION (51206-315-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE 48 carton 2025-10-08 2030-12-31 No No Historical