🇺🇸
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
- ndc1151206311011 TUBE in 1 CARTON (51206-311-01) / 133 g in 1 TUBE
- ndc1151206311023 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
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