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PCXX PEPPERMINT APF F

NDC product · U.S. Food and Drug Administration (openFDA) · United States

  • Product NDC 62007-059
  • Package NDC 62007-059-07
  • SPL ID 3a777df2-0ece-8799-e063-6294a90a3105
  • SPL set ID 5e86783c-414a-5f46-e053-2991aa0abb3b
  • UNII 8ZYQ1474W7
  • RxCUI 248389

What the source publishes

Labeler
Ross Healthcare Inc.
Active ingredients
Sodium Fluoride
Form
AEROSOL, FOAM
Routes
DENTAL, TOPICAL
Administrative status
present-in-source-snapshot
Marketing status
UNAPPROVED DRUG OTHER
Product type
HUMAN PRESCRIPTION DRUG
Prescription
Prescription or restricted

Names this record is found by

Complete source data
us:fda:ndc:62007-059_3a777df2-0ece-8799-e063-6294a90a3105 
{
  "name": "PCXX PEPPERMINT APF F",
  "splId": "3a777df2-0ece-8799-e063-6294a90a3105",
  "labels": [
    {
      "setId": "5e86783c-414a-5f46-e053-2991aa0abb3b",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e86783c-414a-5f46-e053-2991aa0abb3b",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=5e86783c-414a-5f46-e053-2991aa0abb3b"
    }
  ],
  "routes": [
    "DENTAL",
    "TOPICAL"
  ],
  "labeler": "Ross Healthcare Inc.",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "125 g in 1 CAN (62007-059-07)",
      "package_ndc": "62007-059-07",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20171121"
    }
  ],
  "productId": "62007-059_3a777df2-0ece-8799-e063-6294a90a3105",
  "useDomain": "unknown",
  "dosageForm": "AEROSOL, FOAM",
  "productNdc": "62007-059",
  "deaSchedule": null,
  "genericName": "Sodium Fluoride",
  "productType": "HUMAN PRESCRIPTION DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "SODIUM FLUORIDE",
      "strength": ".0272 g/g"
    }
  ],
  "applicationNumber": null,
  "marketingCategory": "UNAPPROVED DRUG OTHER",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20171121",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "unii": [
      "8ZYQ1474W7"
    ],
    "rxcui": [
      "248389"
    ],
    "spl_set_id": [
      "5e86783c-414a-5f46-e053-2991aa0abb3b"
    ],
    "manufacturer_name": [
      "Ross Healthcare Inc."
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20271231"
}

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