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United States · US · US:51206-311_37cb8c52-923b-ff47-e063-6294a90ab925

Opal by Opalescence Sensitivity

In shortageUNIISPLATC C03CB

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

Identification

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

Packs · 2

  • ndc11
    5120631101
    1 TUBE in 1 CARTON (51206-311-01) / 133 g in 1 TUBE
  • ndc11
    5120631102
    3 CARTON in 1 PACKAGE, COMBINATION (51206-311-02) / 1 TUBE in 1 CARTON / 133 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": "DENTAL",
  "spl_meta": {
    "5c3bf8fc-2e8f-4a58-bcbf-e47540072a49": {
      "match": "brand_token",
      "title": "OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]",
      "spl_version": "5",
      "published_date": "2025-06-19"
    }
  },
  "productid": "51206-311_37cb8c52-923b-ff47-e063-6294a90ab925",
  "productndc": "51206-311",
  "dosage_form": "GEL, 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": "Opal by Opalescence Sensitivity",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Potassium Nitrate and Sodium Fluoride",
  "start_marketing_date": "20231119",
  "active_numerator_strength": "50; 1.1"
}

Related drugs

Other records sharing ATC code C03CB.

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