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United States · US · US:66975-780_500d7c21-dc0f-a18a-e063-6394a90ab3ee

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 · 2

  • ndc11
    6697578001
    113 g in 1 TUBE (66975-780-01)
  • ndc11
    6697578002
    24 g in 1 TUBE (66975-780-02)

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; 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": "66975-780_500d7c21-dc0f-a18a-e063-6394a90ab3ee",
  "productndc": "66975-780",
  "dosage_form": "PASTE, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
  "shortage_reason": "Potassium Citrate Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "PRO-SYS",
  "active_ingred_unit": "g/100g; g/100g",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Sensitivity - Mint (OTC)",
  "start_marketing_date": "20251201",
  "active_numerator_strength": "5; .11"
}

Related drugs

Other records sharing ATC code C03CB.

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