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United States · US · US:66975-778_4e5407aa-4a76-dac3-e063-6394a90a6f2a

PRO-SYS

In shortageUNIISPLATC C03CB

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

Identification

ManufacturerBenco Dental
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6697577801
    113 g in 1 TUBE (66975-778-01)

Annotations

UNII (FDA Substance ID)
RU45X2JN0Z
POTASSIUM NITRATE
RxCUI 34316
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Chloride 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; ORAL",
  "spl_meta": {
    "4c9c144a-f28e-756d-e063-6394a90a5971": {
      "match": "brand_token",
      "title": "PRO-SYS (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BENCO DENTAL]",
      "spl_version": "7",
      "published_date": "2026-05-14"
    }
  },
  "productid": "66975-778_4e5407aa-4a76-dac3-e063-6394a90a6f2a",
  "productndc": "66975-778",
  "dosage_form": "PASTE, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
  "shortage_reason": "Potassium Chloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "PRO-SYS",
  "active_ingred_unit": "g/100g; g/100g",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "Potassium Nitrate, Sodium Fluoride",
  "start_marketing_date": "20251201",
  "active_numerator_strength": "5; 1.1"
}

Related drugs

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