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United States · US · US:0135-0810_1fab5aa6-1081-c4f5-e063-6294a90a5d1c

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 · 3

  • ndc11
    0135081001
    23 g in 1 TUBE (0135-0810-01)
  • ndc11
    0135081002
    1 TUBE in 1 CARTON (0135-0810-02) / 96.4 g in 1 TUBE
  • ndc11
    0135081003
    1 TUBE in 1 CARTON (0135-0810-03) / 65.2 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": "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": "0135-0810_1fab5aa6-1081-c4f5-e063-6294a90a5d1c",
  "productndc": "0135-0810",
  "dosage_form": "PASTE",
  "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": "Sensodyne Pronamel",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "potassium nitrate, sodium fluoride",
  "start_marketing_date": "20250106",
  "active_numerator_strength": "50; 1.15"
}

Related drugs

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