Top Care

In shortageUNIISPLATC C03CB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTOPCO Assoc. LLC

CountryUS (United States)

ATC codeC03CB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3680068119
1 TUBE in 1 CARTON (36800-681-19) / 113 g in 1 TUBE

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",
  "spl_meta": {
    "8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c": {
      "match": "brand_token",
      "title": "TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]",
      "spl_version": "9",
      "published_date": "2025-11-18"
    }
  },
  "productid": "36800-681_4395839a-f420-fe45-e063-6394a90a33d3",
  "productndc": "36800-681",
  "dosage_form": "PASTE, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
  "shortage_reason": "Potassium Chloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Top Care",
  "active_ingred_unit": "g/100g; g/100g",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Fluoride",
  "start_marketing_date": "20110120",
  "active_numerator_strength": "5; .15"
}

Related drugs

Other records sharing ATC code C03CB.

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