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 41 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quip Anticavity SODIUM FLUORIDE Quip NYC Inc. b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a 2025-01-30 Warnings Exact identifier application number: M021 Quip SODIUM FLUORIDE Quip NYC Inc. 714b7205-444d-929b-e053-2995a90a958e 2025-01-30 Warnings Exact identifier application number: M021 Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4 2025-01-29 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DOCSMEDI Co., Ltd. ea18ac56-4ef1-4bf0-8c26-6885183fd684 2025-01-22 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DOCSMEDI Co., Ltd. aaf08481-a2ff-48f6-8611-73a469efe1db 2025-01-22 Warnings Exact identifier application number: M021 Double X CONCENTRATED CETYLPYRIDINIUM CHLORIDE DOCSMEDI Co., Ltd. 411be334-364c-4074-8d0b-8dda332f87de 2025-01-22 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude d33e3778-ba1d-4560-bafa-74f7ab88c6b5 2025-01-20 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE gel SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 86279b4d-82e5-45b5-9ba7-94fe3620b850 2025-01-16 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 2025-01-16 Warnings Exact identifier application number: M021 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 2025-01-16 Warnings Exact identifier application number: M021 Medpride SODIUM MONOFLUOROPHOSPHATE Shield Line LLC 9c1b0420-6b57-4914-99fe-df6a494815c3 2025-01-16 Warnings Exact identifier application number: M021 Sodium Fluoride SODIUM FLUORIDE Safco Dental Supply LLC 7a295974-c400-4442-9149-138a805ffb20 2025-01-09 Warnings Exact identifier application number: M021 Salivea FLUORIDE TOOTHPASTE Laclede, Inc. 6398ae96-dd38-44da-bc34-1d4d4c4a78ca 2025-01-08 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 098a29d5-3836-d362-e063-6394a90a9fea 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Sensitivity Care Prebiotic Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Sensitive Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. dec29c9f-6ddb-0b4e-e053-2995a90a64b1 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Original Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8e5de76b-535a-9c95-e053-2995a90afcab 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8f27c88a-7a70-e00a-e053-2a95a90a95a4 2025-01-01 Warnings Exact identifier application number: M021 POP Feeling Peachy SODIUM FLUORIDE TAI GUK PHARM. CO., LTD 0abb7a95-60b1-a1f3-e063-6294a90ace0c 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 99fff177-6300-220e-e053-2a95a90a0660 2025-01-01 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