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 46 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor SODIUM FLUORIDE Ashtel Studios Inc. bbf6cfe7-c5e5-4e63-ac7d-4535a0ca3973 2024-07-31 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 32780fe9-82bf-42f8-8218-bed5bc579c72 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 7ba8cff2-92a4-4432-aaf3-50358d9483a2 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ed057c95-90cd-4edb-ac00-78db8f6a065b 2024-07-29 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. f01c5eaf-7e81-4b30-bb6f-50566a727364 2024-07-29 Warnings Exact identifier application number: M021 Sodium Monofluorophosphate WHITE TOOTHPASTE Dynarex Corporation 1be422b9-6320-ed5c-e063-6294a90a7e42 2024-07-03 Warnings Exact identifier application number: M021 Wpgcng Antiacvity Fluoride Mouthwash SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 5756206e-43cc-8cc7-e063-6394a90a2950 2024-07-03 Warnings Exact identifier application number: M021 dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum SODIUM FLUORIDE Lidl US, LLC 0c77ba33-acb9-4c83-aa75-7d5c82f903eb 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE WHITENING MINT SODIUM FLUORIDE Lidl US, LLC 37011052-16ef-4ae4-aade-a86f9fa9cdac 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Lidl US, LLC ccf54743-81c2-43f8-9c5c-d4baa85fc18d 2024-07-02 Warnings Exact identifier application number: M021 SmileSense STANNOUS FLUORIDE SGII, INC 1c371393-da75-c9c8-e063-6294a90a5840 2024-07-01 Warnings Exact identifier application number: M021 Sodium Fluoride CLEAR MINT, GEL TOOTHPASTE Dynarex Corporation 1be193b6-4c07-4f0a-e063-6394a90a32c7 2024-06-27 Warnings Exact identifier application number: M021 CREST CAVITY PROTECTION COOL MINT SODIUM FLUORIDE A-S Medication Solutions dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d 2024-06-12 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. a37e9d9c-dca9-4d58-a716-4514ebe8ec88 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 0e6b01a4-1132-489f-936c-d3a54e9e21e0 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ffb8c43c-8f45-42ec-83eb-f0c83f7f99f8 2024-06-11 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 1a26ad70-9773-dc4f-e063-6294a90ac333 2024-05-31 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE LG H&H Co.,Ltd. 1a01481f-3e02-634e-e063-6394a90ac5fc 2024-05-31 Warnings Exact identifier application number: M021 Brush Buddies - Hot Wheels ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios Inc. 86dd5e9c-71c3-46ce-ae4c-45d19468667d 2024-05-29 Warnings Exact identifier application number: M021 Dentalclean Doctor Duck Kids Flouride Mouthwash SODIUM FLUORIDE 0.02% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 18806738-82fa-1a37-e063-6294a90a3888 2024-05-15 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