🇺🇸
United States · US · US:36800-364_47e514c6-af35-cdd8-e063-6394a90aea44
Topco Associates LLC
In shortageUNIISPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1136800364101 TUBE in 1 CARTON (36800-364-10) / 113 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": "DENTAL",
"spl_meta": {
"ecf87660-f552-1f6b-e053-2a95a90a2486": {
"match": "brand_token",
"title": "TOPCO ASSOCIATES (SELENIUM SULFIDE) SHAMPOO [TOPCO ASSOCIATES]",
"spl_version": "5",
"published_date": "2026-05-11"
}
},
"productid": "36800-364_47e514c6-af35-cdd8-e063-6394a90aea44",
"productndc": "36800-364",
"dosage_form": "PASTE, DENTIFRICE",
"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": "Topco Associates LLC",
"active_ingred_unit": "g/100g; g/100g",
"application_number": "M022",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Fluoride",
"start_marketing_date": "20250626",
"active_numerator_strength": "5; .15"
}Related drugs
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