Home NDC 51206-451 Opalescence Sensitivity Relief Whitening
Product NDC 51206-451
11-digit product format 512060451
Labeler code 51206
Product ID 51206-451_5d5c2b00-d33f-797b-e063-6294a90aefea
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 2026-07-16
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.1 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.1 mg/g
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51206-451-01 51206045101 1 TUBE in 1 CARTON (51206-451-01) / 133 g in 1 TUBE 1 tube 2026-07-16 No No Current 51206-451-02 51206045102 12 CARTON in 1 PACKAGE, COMBINATION (51206-451-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 12 carton 2026-07-16 No No Current 51206-451-03 51206045103 1 TUBE in 1 CARTON (51206-451-03) / 28.35 g in 1 TUBE 1 tube 2026-07-16 No No Current 51206-451-04 51206045104 24 CARTON in 1 PACKAGE, COMBINATION (51206-451-04) / 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE 24 carton 2026-07-16 No No Current 51206-451-05 51206045105 48 TUBE in 1 PACKAGE, COMBINATION (51206-451-05) / 28.35 g in 1 TUBE 48 tube 2026-07-16 No No Current