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 32 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 8b28b857-9162-4065-b0a0-571efffe9787 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Ortho SODIUM FLUORIDE Dr Jen Natural, LLC 9dd248bf-9488-43cd-a041-e8315a05ce5d 2025-12-04 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Perio SODIUM FLUORIDE Dr Jen Natural, LLC 8c7e6d3a-49d9-4098-9d5e-e9792b373574 2025-12-04 Warnings Exact identifier application number: M021 Colgate Total Plaque Cleanse STANNOUS FLUORIDE Colgate-Palmolive Company b2980238-5bcb-467f-9e90-a307938632c2 2025-12-03 Warnings Exact identifier application number: M021 Advance White Extreme Whitening Tartar Control SODIUM FLUORIDE Church & Dwight Co., Inc. b539264f-e1ff-440b-af76-84266fe2c0a2 2025-12-02 Warnings Exact identifier application number: M021 Sensodyne Pronamel Clinical Enamel Strength Fresh Breath POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 34a1a32e-3017-f018-e063-6394a90a0230 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE AND POTASSIUM NITRATE Benco Dental 4e470ba4-60bb-1815-e063-6294a90abacc 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE Benco Dental 4e539cb2-bcbd-95fc-e063-6294a90a2121 2025-12-01 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DONG IL PHARMS CO., LTD. 44763bf6-caf3-ec69-e063-6394a90a0ee1 2025-11-25 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 44765e86-2eb2-6381-e063-6394a90a761f 2025-11-25 Warnings Exact identifier application number: M021 TheraBreath for Kids Anticavity Wacky Watermelon SODIUM FLUORIDE Church & Dwight Co., Inc. 578f8010-6b1c-4c6b-91d3-e483ace40f66 2025-11-25 Warnings Exact identifier application number: M021 Sensodyne Cavity and Sensitivity POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC d002074b-0580-4247-b3c7-121b8c098697 2025-11-24 Warnings Exact identifier application number: M021 CVS Pharmacy Enamel Guard FLUORIDE CVS Pharmacy 18295a1c-c2a6-489b-be34-9252b9e1e2b8 2025-11-21 Warnings Exact identifier application number: M021 365 Everyday Value Cavity Fighting and Whitening SODIUM MONOFLOUROPHOSPHATE Whole Foods Market, Inc. 83704717-19bc-2634-e053-2991aa0a2979 2025-11-21 Warnings Exact identifier application number: M021 Whitening MONOFLUOROPHOSPHATE Target 0074630f-9d8d-9209-e063-6294a90a4f01 2025-11-21 Warnings Exact identifier application number: M021 Rite Aid Enamel Guard FLUORIDE Rite Aid 67c1fc04-0f21-4944-8b9d-0d8ffd051874 2025-11-21 Warnings Exact identifier application number: M021 ME MOTHER EARTH ZERO WASTE TOOTHPASTE TABLETS PEPPERMINT A PLUS MERCHANDISE LLC 43d30abc-889a-5377-e063-6294a90ab804 2025-11-17 Warnings Exact identifier application number: M021 Natural White Sensitivity and Gum STANNOUS FLUORIDE Lornamead Products 2e83bda8-4d4b-640f-e063-6294a90abc60 2025-11-14 Warnings Exact identifier application number: M021 CVS Pharmacy Restore and Defend FLUORIDE CVS Pharmacy 99f86135-05b7-42b1-aef5-df4513259b8f 2025-11-14 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