🇺🇸
United States · US · US:11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480
Sodium Fluoride 5000 ppm Enamel Protect
In shortageUNIISPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSheffield Pharmaceuticals LLC
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1111527745341 TUBE in 1 CARTON (11527-745-34) / 100 mL 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": {
"52430b12-4d5f-d1e1-e063-6394a90abd64": {
"match": "brand_token",
"title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480",
"productndc": "11527-745",
"dosage_form": "GEL, DENTIFRICE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"shortage_reason": "Potassium Chloride Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "Sodium Fluoride 5000 ppm Enamel Protect",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": null,
"marketing_category": "UNAPPROVED DRUG OTHER",
"nonproprietary_name": "Sodium Fluoride1.1%, Potassium Nitrate 5%",
"start_marketing_date": "20210108",
"active_numerator_strength": "57.5; 5.8"
}Related drugs
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