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United States · US · US:59883-031_2cf0556f-5090-c02c-e063-6394a90a4b40

FLUORIDEX

In shortageUNIISPLATC C03CB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDENT-MAT HOLDINGS, LLC.
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5988303104
    1 TUBE in 1 BOX (59883-031-04) / 112 g in 1 TUBE
  • ndc11
    5988303105
    24 g in 1 TUBE (59883-031-05)

Annotations

UNII (FDA Substance ID)
RU45X2JN0Z
POTASSIUM NITRATE
RxCUI 34316
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Citrate Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "RU45X2JN0Z",
    "rxcui": "34316",
    "inchikey": "FGIUAXJPYTZDNR-UHFFFAOYSA-N",
    "display_name": "POTASSIUM NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "DENTAL",
  "spl_meta": {
    "601774d5-f4de-01bc-e053-2991aa0a7f4f": {
      "match": "brand_token",
      "title": "FLUORIDEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENT-MAT HOLDINGS, LLC.]",
      "spl_version": "5",
      "published_date": "2025-01-31"
    }
  },
  "productid": "59883-031_2cf0556f-5090-c02c-e063-6394a90a4b40",
  "productndc": "59883-031",
  "dosage_form": "PASTE, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
  "shortage_reason": "Potassium Citrate Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "FLUORIDEX",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "Sodium Fluoride",
  "start_marketing_date": "20161221",
  "active_numerator_strength": "50; 5"
}

Related drugs

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