Label: OPAL BY OPALESCENCE ORIGINAL- sodium fluoride gel, dentifrice

  • NDC Code(s): 51206-312-01, 51206-312-02
  • Packager: Ultradent Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sodium Fluoride 0.25% w/w

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental decay.

  • Warnings

    Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Other Information

    • Do not use if tamper-evident seal is broken
    • Store at room temperature
    • Contains FD&C Yellow No. 5 (tartrazine) as a color additive
  • Inactive Ingredients

    Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum

  • Questions or comments

    Call toll-free 1.800.496.8330

  • PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton

    opal™
    by Opalescence ®

    Whitening
    Toothpaste

    ORIGINAL
    COOL MINT

    FLUORIDE TOOTHPASTE
    NET WT. 4.7 OZ

    Principal Display Panel - 4.7 OZ Tube Carton
  • INGREDIENTS AND APPEARANCE
    OPAL BY OPALESCENCE ORIGINAL 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-312
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51206-312-023 in 1 PACKAGE, COMBINATION11/19/2023
    1NDC:51206-312-011 in 1 CARTON
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/19/2023
    Labeler - Ultradent Products, Inc. (013369913)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultradent Products, Inc.013369913manufacture(51206-312) , analysis(51206-312) , label(51206-312) , pack(51206-312)
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