Label: ORALLINE SECURE- sodium fluoride paste, dentifrice
ORALLINE- sodium fluoride gel, dentifrice

  • NDC Code(s): 55873-001-01, 55873-002-01
  • Packager: J.M. Murray Center Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 23, 2019

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  • Active Ingredient

    Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

  • Inactive Ingredients

    Sorbitol, Hydrated Silica, DI Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Titanium Dioxide, Sodium Saccharin, FD C Blue 1

  • Purpose

    Anticavity Toothpaste

  • Use

    Use - Helps protect against cavities

  • 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. 

    Children under 6 years of age.  Use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing.  Supervise children as necessary until capable of using without supervision.

  • Warnings

    If you accidentally swallow more than used for brushing get medical help or contact a poison control center immediately.

  • Keep Out of Reach of Children

    Children under 2 years of age consult a doctor or a dentist

    Keep out of the reach of children under 6 years of age.

  • Product Labels

    OraLine Fluoride Toothpaste  ADA accepted.The ADA Council on Scientific Affairs Acceptance of OraLine Fluoride Mint Toothpaste is based on finding that the product is effective in helping to prevent and reduce tooth decay when used as directed

    No animal based ingredients.  Mint Flavor  Net Wt 3 oz (85 g)

    Murray_oraline_fluoride

    Murray_oraline_fluoride_clear

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  • INGREDIENTS AND APPEARANCE
    ORALLINE SECURE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55873-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55873-001-0185 g in 1 TUBE; Type 0: Not a Combination Product01/01/1966
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/1966
    ORALLINE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55873-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55873-002-0185 g in 1 TUBE; Type 0: Not a Combination Product01/01/1966
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/1966
    Labeler - J.M. Murray Center Inc. (071601108)
    Registrant - J.M. Murray Center Inc. (071601108)
    Establishment
    NameAddressID/FEIBusiness Operations
    J.M. Murray Center Inc.071601108repack(55873-001, 55873-002) , relabel(55873-001, 55873-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies, Inc.148312838manufacture(55873-001, 55873-002)
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