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 20 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Mouth Sore Relief BENZOCAINE Walgreens 253d7ea2-e48e-c7d7-e063-6394a90ae001 2025-08-12 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE Gel SODIUM FLUORIDE Yangzhou Hongshengding Chemical Co.,Ltd. 897b0102-1c96-4699-908e-a7b7e26cd29f 2025-08-08 Warnings Exact identifier application number: M022 Meijer Enamel Guard POTASSIUM NITRATE, SODIUM FLUORIDE Meijer Distribution Inc 82bc95be-0a07-3f00-e053-2a91aa0a7438 2025-08-08 Warnings Exact identifier application number: M022 Topco Associates LLC Maximum Strength FLUORIDE Topco Associates LLC ac398ff0-0010-4e13-8b89-dc986fd7f974 2025-08-08 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE PLUS SOOTHING ALOE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 4ae4e88a-aaa5-4195-bedc-622fd5cd9394 2025-07-30 Warnings Exact identifier application number: M022 Aseptil Rojo PHENOL Menper Distributors, Inc. 62c96dc1-4698-43c1-8e6d-f4062dc5eea2 2025-07-22 Warnings Exact identifier application number: M022 Anestenka BENZOCAINE Menper Distributors, Inc 00a3f1bc-ddfe-47c6-8221-f48f91513503 2025-07-22 Warnings Exact identifier application number: M022 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier application number: M022 SprinJene Natural Sensitivity and Gum POTASSIUM NITRATE Health and Natural Beauty USA Corp 3cb23e36-0e8c-4172-b4ae-859b58a2739f 2025-07-07 Warnings Exact identifier application number: M022 Normal Salt SODIUM CHLORIDE Twin Med LLC dc82ff0f-8600-373a-e053-2995a90a7505 2025-07-03 Warnings Exact identifier application number: M022 Sensodyne Pronamel Kids Berry Twist SODIUM FLUORIDE Haleon US Holdings LLC 69c07c36-b5e0-420b-ab29-7d1091386322 2025-07-03 Warnings Exact identifier application number: M022 DenTek Instant Pain Relief Maximum Strength BENZOCAINE DenTek Oral Care, Inc. ae92b76e-815a-4b4c-8128-bd045098caa5 2025-06-30 Warnings Exact identifier application number: M022 Sensodyne Clinical White Stain Protector POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 99037e59-53d6-492c-8fce-67641fc8efdd 2025-06-25 Warnings Exact identifier application number: M022 Iolite-S BENZOCAINE Dharma Research, Inc. b3b68914-2adc-4f07-9521-0b18756be522 2025-06-14 Warnings Exact identifier application number: M022 Red Cross Toothache EUGENOL The Mentholatum Company 3537e599-65d9-48d6-8a46-d42312f71e84 2025-06-11 Warnings Exact identifier application number: M022 QUALITY CHOICE Sore Throat PHENOL CHAIN DRUG MARKETING ASSOCIATION c95ee086-f384-475d-ad0c-75518cb9d2fe 2025-06-10 Warnings Exact identifier application number: M022 Onral Oral Pain Reliever Mouthwash BENZOCAINE Syka Pharma Inc. 5dd8d933-6f32-4eaf-8eca-9365d7de55a2 2025-06-03 Warnings Exact identifier application number: M022 Orajel Rescue Relief Pen ORAL PAIN RELIEVER Church & Dwight Co., Inc. 2d68eec5-ae8a-9cdf-e063-6294a90a9799 2025-06-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 9e1f7462-a052-4db4-bc59-cce437b695d0 2025-05-20 Warnings Exact identifier application number: M022 Saline 1.5 FL OZ SALINE ALAINA HEALTHCARE PRIVATE LIMITED f1bdbb25-6943-4828-9ae0-7d9783c18b5f 2025-05-19 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