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United States · US · US:61596-400_4651d664-464b-05c1-e063-6394a90a565e

MIPaste One

In shortageUNIISPLATC C03CB

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

Identification

ManufacturerGC America Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6159640010
    10 BOX in 1 BOX (61596-400-10) / 1 TUBE in 1 BOX (61596-400-41) / 46 g in 1 TUBE (61596-400-40)

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": {
    "1b68bd67-65d3-4c64-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]",
      "spl_version": "10",
      "published_date": "2026-05-13"
    }
  },
  "productid": "61596-400_4651d664-464b-05c1-e063-6394a90a565e",
  "productndc": "61596-400",
  "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": "MIPaste One",
  "active_ingred_unit": "g/100g; g/100g",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "MIPaste One",
  "start_marketing_date": "20220203",
  "active_numerator_strength": "5; .24"
}

Related drugs

Other records sharing ATC code C03CB.

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