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United States · US · US:36800-362_400555cb-e40f-5d08-e063-6394a90a160a

Intensive Enamel Repair Whitening TP

In shortageUNIISPLATC C03CB

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3680036210
    1 TUBE in 1 CARTON (36800-362-10) / 96.4 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 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": "ORAL",
  "spl_meta": {
    "3012a8da-7595-2f7c-e063-6294a90ae120": {
      "match": "brand_token",
      "title": "INTENSIVE ENAMEL REPAIR WHITENING TP PASTE, DENTIFRICE [TOPCO ASSOCIATES LLC]",
      "spl_version": "4",
      "published_date": "2025-10-02"
    }
  },
  "productid": "36800-362_400555cb-e40f-5d08-e063-6394a90a160a",
  "productndc": "36800-362",
  "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": "Intensive Enamel Repair Whitening TP",
  "active_ingred_unit": "g/100g; g/100g",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Intensive Enamel Repair Whitening TP",
  "start_marketing_date": "20250617",
  "active_numerator_strength": "5; .15"
}

Related drugs

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