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United States · US · US:0135-0700_12dd7448-a7e1-9b94-e063-6394a90a6d48

SENSODYNE PRONAMEL

In shortageUNIISPLATC C03CB

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

Identification

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

Packs · 2

  • ndc11
    0135070001
    1 TUBE in 1 CARTON (0135-0700-01) / 96.4 g in 1 TUBE
  • ndc11
    0135070002
    23 g in 1 TUBE (0135-0700-02)

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": "ORAL",
  "spl_meta": {
    "a2f9d58b-671b-4427-a971-1fceff5f2323": {
      "match": "brand_token",
      "title": "SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]",
      "spl_version": "10",
      "published_date": "2026-03-10"
    }
  },
  "productid": "0135-0700_12dd7448-a7e1-9b94-e063-6394a90a6d48",
  "productndc": "0135-0700",
  "dosage_form": "PASTE",
  "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": "SENSODYNE PRONAMEL",
  "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": "20230102",
  "active_numerator_strength": "50; 1.15"
}

Related drugs

Other records sharing ATC code C03CB.

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