Home NDC 51206-302 Opalescence Whitening
Product NDC 51206-302
11-digit product format 512060302
Labeler code 51206
Product ID 51206-302_5b14d90f-23ec-372b-e063-6294a90a2066
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 1994-07-01
Marketing end 2030-09-30
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 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 1044547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51206-302-06 Opalescence Whitening 133 g in 1 TUBE GEL, DENTIFRICE 133 9 51206-302-06 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-07 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-07 Opalescence Whitening 28.35 g in 1 TUBE GEL, DENTIFRICE 28.35 9 51206-302-08 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-08 Opalescence Whitening 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 9 51206-302-09 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-09 Opalescence Whitening 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 9 51206-302-10 Opalescence Whitening 24 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 24 9 51206-302-10 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-11 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-11 Opalescence Whitening 6 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 6 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Fluoride ACTIVE INGREDIENT 8ZYQ1474W7 OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Fluoride Ion ACTIVE MOIETY Q80VPU408O OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 FD&C Yellow No. 5 INACTIVE INGREDIENT I753WB2F1M OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Methyl Salicylate INACTIVE INGREDIENT LAV5U5022Y OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Xylitol INACTIVE INGREDIENT VCQ006KQ1E OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-302 OPALESCENCE WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC] 7 Current NDC, Legacy NDC, 12 package rows 20240224_d07f842e-b6f1-4ae1-b576-f542ecd02dd4.zip
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 37 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE Acuseplanet Inc 3c0e1862-293f-4d23-e063-6294a90a33e1 2025-08-10 Warnings Exact identifier application number: M021 Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc. 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 2025-07-28 Warnings Exact identifier application number: M021 Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc e7aa2a8d-7140-4718-bf69-917bb50d32c7 2025-07-28 Warnings Exact identifier application number: M021 Dubai Chocolate Flavor ANTICAVITY TOOTHPASTE SuperMouth, LLC. d1615a53-ecfc-49d1-b836-f7643b9d2660 2025-07-24 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. 0c7ede82-3b28-40ae-8dfd-cec58825f938 2025-07-23 Warnings Exact identifier application number: M021 Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Brush Buddies Oral Rinse Sparkle Mint SODIUM FLUORIDE ASHTEL STUDIOS, INC fe2c06fc-6497-4888-877f-1a88e02fad20 2025-07-15 Warnings Exact identifier application number: M021 evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 1620c7fa-2af6-4462-af5d-9e122942788a 2025-07-15 Warnings Exact identifier application number: M021 Dentalclean Green Diamond Alcohol Free Mouthwash SODIUM FLUORIDE 0.05% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 5653aa33-4f0e-46b2-9be0-6219143556ec 2025-07-14 Warnings Exact identifier application number: M021 Colgate Total Gum Protect Fresh Mint STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 570e3bd6-eede-4270-9d78-055aeb2b8c17 2025-07-14 Warnings Exact identifier application number: M021 OraPro Fluoride Anticavity FLUORIDE TOOTHPASTE Protegera, Inc. 93b0181c-e29f-42f4-80f5-366463b68f09 2025-07-10 Warnings Exact identifier application number: M021 Enamur Fluoride AntiCavity Toothpast FLUORIDE TOOTHPAST Protegera, Inc 557ced45-f54e-43d8-aa13-46f75b79367c 2025-07-10 Warnings Exact identifier application number: M021 Super Strawberry STRAWBERRY TOOTHPASTE SuperMouth, LLC. a8c2b68d-d28b-41c0-a383-cc706b25aa1a 2025-07-05 Warnings Exact identifier application number: M021 Super Mint SUPER MINT TOOTHPASTE SuperMouth, LLC. be0915f3-36c4-4200-9d15-704cfbd632b4 2025-07-05 Warnings Exact identifier application number: M021 Super Vanilla VANILLA TOOTHPASTE SuperMouth, LLC. 3ddfe20a-86f1-4566-bb77-82c9749411f6 2025-07-05 Warnings Exact identifier application number: M021 Super Chocolate CHOCOLATE TOOTHPASTE SuperMouth, LLC. 48607622-7c5e-4ddc-8d83-707f26c0553f 2025-07-05 Warnings Exact identifier application number: M021 Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. 13dba3ce-88a8-490c-a906-cfd206d1d290 2025-07-01 Warnings Exact identifier application number: M021 evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. baae4f4a-54ef-472a-9c94-31703435750b 2025-07-01 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 51206-302-06 51206030206 1 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE 1 tube 1994-07-01 2030-09-30 No No Current 51206-302-07 51206030207 1 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE 1 tube 1994-07-01 2030-09-30 No No Current 51206-302-08 51206030208 3 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 3 box 2016-06-01 2030-09-30 No No Current 51206-302-09 51206030209 12 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 12 box 2016-06-01 2030-09-30 No No Current 51206-302-10 51206030210 24 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE 24 box 2016-06-01 2030-09-03 No No Current 51206-302-11 51206030211 6 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 6 box 2020-08-24 2030-09-30 No No Current