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United States · US · US:58578-0749_4aab2169-2fe1-4d9b-94a0-45724392e6bc
CloSYS
In shortageUNIISPLATC A01AA51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRowpar Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA01AA51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1158578074911 TUBE in 1 BOX (58578-0749-1) / 96 g in 1 TUBE
- ndc1158578074921 TUBE in 1 BOX (58578-0749-2) / 198 g in 1 TUBE
- ndc1158578074942 TUBE in 1 PACKAGE (58578-0749-4) / 198 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8ZYQ1474W7
SODIUM FLUORIDE
RxCUI 9873
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
"unii": {
"unii": "8ZYQ1474W7",
"rxcui": "9873",
"inchikey": "PUZPDOWCWNUUKD-UHFFFAOYSA-M",
"display_name": "SODIUM FLUORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "DENTAL; ORAL",
"spl_meta": {
"11fd3f31-ee0c-43d2-a856-929d1298277c": {
"match": "brand_token",
"title": "CLOSYS SILVER HEALTHY GUMS (CETYLPYRIDINIUM CHLORIDE) LIQUID [ROWPAR PHARMACEUTICALS, INC.]",
"spl_version": "5",
"published_date": "2026-04-08"
}
},
"productid": "58578-0749_4aab2169-2fe1-4d9b-94a0-45724392e6bc",
"productndc": "58578-0749",
"dosage_form": "PASTE, DENTIFRICE",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "SODIUM FLUORIDE",
"shortage_reason": "Sodium Chloride 0.9% Injection",
"shortage_status": "current",
"proprietary_name": "CloSYS",
"active_ingred_unit": "mg/g",
"application_number": "M021",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Sodium Fluoride",
"start_marketing_date": "20171020",
"active_numerator_strength": "1.1"
}Related drugs
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