Home NDC 51206-314 Opalescence Whitening
Product NDC 51206-314
11-digit product format 512060314
Labeler code 51206
Product ID 51206-314_5b14bdd2-2852-1c00-e063-6294a90ac4cc
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-23
Marketing end 2031-01-31
Substance SODIUM FLUORIDE
Active strength 1.1 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
Brand name suffix Cool Mint Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 416783 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 51206-314-01 Opalescence WhiteningCool Mint 133 g in 1 TUBE GEL, DENTIFRICE 133 3 51206-314-01 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-02 Opalescence WhiteningCool Mint 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 3 51206-314-02 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-03 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-03 Opalescence WhiteningCool Mint 28 g in 1 TUBE GEL, DENTIFRICE 28 3 51206-314-04 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3 51206-314-04 Opalescence WhiteningCool Mint 24 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 24 3 51206-314-05 Opalescence WhiteningCool Mint 48 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 48 3 51206-314-05 Opalescence WhiteningCool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 3
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 42 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05a9cee1-bd6e-6b93-e063-6294a90a5c10 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Advanced Whitening Prebiotic Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f546470a-7fae-4988-e053-2995a90ab61b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Whitening Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de97dbea-dc8c-ebfa-e053-2995a90a2270 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b1020b-a1c3-e1eb-e063-6394a90ac266 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Complete Protection Prebiotic Mint Blast SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f547a468-d2fd-7176-e053-2995a90a5539 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. b4530d56-3a17-6868-e053-2995a90a2524 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Total Care Strong Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de996aeb-9ac0-836f-e053-2a95a90aeda6 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05aafc53-49ca-eacd-e063-6394a90a606b 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b18bb6-9fbf-469b-e063-6294a90a4f2f 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 9c820740-9148-3a9c-e053-2a95a90a3968 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials Fresh Aloe Green Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. a3b21ceb-5aa5-29b4-e053-2a95a90a9545 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE LG H&H Co., Ltd. 05b25897-460c-2dfb-e063-6294a90ada3b 2025-01-01 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H Co., Ltd. 05b1f105-6f75-7a45-e063-6394a90a58bc 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE LG H&H Co., Ltd. 05b25083-12f3-7a85-e063-6394a90a492e 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE LG H&H Co., Ltd. 05b276a1-3778-104d-e063-6294a90a7537 2025-01-01 Warnings Exact identifier application number: M021 kids kare STANNOUS FLUORIDE DEN-MAT HOLDINGS, LLC. 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91 2024-12-31 Warnings Exact identifier application number: M021 Kids Kare SODIUM FLUORIDE DEN-MAT HOLDINGS, LLC. 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca 2024-12-31 Warnings Exact identifier application number: M021 Morning Fresh SODIUM FLUORIDE Dynarex Corporation 1d0457d7-0228-4ea3-9755-73bacd2201e6 2024-12-27 Warnings Exact identifier application number: M021 Bubble Fresh Toothpaste, with Fluoride BUBBLE FRESH TOOTHPASTE, WITH FLUORIDE Dynarex Corporation 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6 2024-12-26 Warnings Exact identifier application number: M021 Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios, Inc. b3006c29-1f7f-4d9f-ab46-5a36df1a0471 2024-12-25 Warnings Exact identifier application number: M021
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 51206-314-01 51206031401 1 TUBE in 1 CARTON (51206-314-01) / 133 g in 1 TUBE 1 tube 2025-09-23 2031-01-31 No No Historical 51206-314-02 51206031402 12 CARTON in 1 PACKAGE, COMBINATION (51206-314-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 12 carton 2025-09-23 2031-01-30 No No Historical 51206-314-03 51206031403 1 TUBE in 1 CARTON (51206-314-03) / 28 g in 1 TUBE 1 tube 2025-09-23 2030-11-30 No No Historical 51206-314-04 51206031404 24 CARTON in 1 PACKAGE, COMBINATION (51206-314-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE 24 carton 2025-09-23 2030-11-30 No No Historical 51206-314-05 51206031405 48 CARTON in 1 PACKAGE, COMBINATION (51206-314-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE 48 carton 2025-09-23 2030-10-31 No No Historical