{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CrystLCare Regeneration Plus Potassium Nitrate, Sodium Fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION PULLULAN GLYCERIN STEVIA REBAUDIANA WHOLE PEPPERMINT OIL WATER CALCIUM PHOSPHATE ION STARCH, CORN"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Potassium Nitrate 5% Sodium Fluoride 0.05%"
      ],
      "purpose": [
        "PURPOSE Antisensitivity Anticavity"
      ],
      "indications_and_usage": [
        "USES Aids in the prevention of dental caries (cavities) Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact"
      ],
      "warnings": [
        "WARNINGS For topical intraoral use only. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product for more than 4 weeks unless recommended by a dentist or doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for daily application is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "DIRECTIONS adults and children 6 years of age and older: Use once a day after brushing teeth with toothpaste followed by rinsing with water. Apply dental strip onto the teeth. Allow to remain on the teeth for 3 min and then spit out residue. Do not eat or drink for 30 minutes. Instruct children under 12 years of age in the use of this product. Supervise children as necessary until capable of using without supervision. children under the age of 6: Consult a dentist."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENT SECTION Calcium/phosphate loaded starch particle (contains Calcium, Phosphate, Starch), natural peppermint oil, pullulan, stevia, vegetable glycerin, water."
      ],
      "questions": [
        "QUESTIONS 1-810-899-0710"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 14 POUCH CARTON CrystLCare REGENERATION + 14 ANTICAVITY & ANTISENSITIVITY DISSOLVABLE DENTAL STRIPS Potassium Nitrate 5% - Sodium Fluoride 0.05% IMPORTANT: Read directions for proper use Peel – Apply – Heal – Protect POWERED by Dentulu Rx ONLY CrystLCare REGENERATION Principal Display Panel",
        "PACKAGE LABEL - 14 POUCH CARTON OUTER PACKAGING - COMPLETE CARTON LABEL CrystLCare REGENERATION Outer Packaging"
      ],
      "set_id": "4f86d0a0-d73e-5605-e063-6394a90adb38",
      "id": "4f86d0a0-d73f-5605-e063-6394a90adb38",
      "effective_time": "20260914",
      "version": "1",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "CrystLCare Regeneration Plus"
        ],
        "generic_name": [
          "POTASSIUM NITRATE, SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "GreenMark Biomedical Inc."
        ],
        "product_ndc": [
          "87587-250"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM NITRATE",
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "4f86d0a0-d73f-5605-e063-6394a90adb38"
        ],
        "spl_set_id": [
          "4f86d0a0-d73e-5605-e063-6394a90adb38"
        ],
        "package_ndc": [
          "87587-250-50",
          "87587-250-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RU45X2JN0Z",
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}