{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Pro-Den Rx Stannous Fluoride GLYCERIN METHYLPARABEN PROPYLPARABEN SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION MINT"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information For your protection, do not use if seal under the cap is broken or missing."
      ],
      "active_ingredient": [
        "Active Ingredient Stannous Fluoride 0.63% w/w (0.19% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose anticavity"
      ],
      "indications_and_usage": [
        "Uses Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity"
      ],
      "warnings": [
        "Warnings When using this product it may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Keep out of reach of children. If more than used for rinsing s accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product it may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing s accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Do not use before mixing with water Use immediately after preparing the rinse Adults and children 6 years of age and older: Use as directed by a dental professional Use once a day after brushing your teeth with a toothpaste or as directed by your dentist Remove cap and seal and replace with pump Rotate spout counter clockwise to extend Depress pump until medicine comes to the tip of the pump Put 1/8 oz. (approx. 2 pump strokes) of concentrated Pro-DenRx Rinse into the provided mixing vial Add water to 1 oz. line on mixing vial Tightly snap on the cap and shake well Vigorously swish between your teeth 1/2 of mixture for one minute and then spit out Repeat procedure with remaining mixture Rinse mixing vial with water after use Do not swallow the rinse Do not eat or drink for 30 minutes after rinsing Children 6 to 12 years of age: Instruct children in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age: Consult a dentist or doctor For home irrigation Prepare 1 oz. of Pro-DenRx Rinse as described above Pour into irrigator reservoir, add 4 oz. of water and mix thoroughly Use irrigator as directed Rinse irrigator with water after use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients flavor, glycerin, methylparaben, propylparaben, sodium saccharin"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - Carton Label NDC 59883-720-08 pro-denRx ® dye free rinse 0.63 % stannous fluoride cool mint flavor IMPORTANT: Read directions for proper use. 10 fl. oz. (283.5 g) Figure",
        "Principal Display Panel NDC 59883-720-08 pro-denRx ® dye free rinse 0.63 % stannous fluoride mint flavor IMPORTANT: Read directions for proper use. 10 fl. oz. (283.5 g) Figure"
      ],
      "set_id": "9036aa8a-59b1-41b0-b3cb-529d3303a1c0",
      "id": "0a95fcbe-e811-031d-e063-6294a90aec1b",
      "effective_time": "20231120",
      "version": "6",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Pro-Den Rx"
        ],
        "generic_name": [
          "STANNOUS FLUORIDE"
        ],
        "manufacturer_name": [
          "Den-mat Holdings, Llc"
        ],
        "product_ndc": [
          "59883-720"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "STANNOUS FLUORIDE"
        ],
        "spl_id": [
          "0a95fcbe-e811-031d-e063-6294a90aec1b"
        ],
        "spl_set_id": [
          "9036aa8a-59b1-41b0-b3cb-529d3303a1c0"
        ],
        "package_ndc": [
          "59883-720-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3FTR44B32Q"
        ]
      }
    }
  ]
}