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United States · US · US:58578-0517_5b621757-befa-4ce3-920d-b884aca94420

CloSYS Silver Sensitive Mouth Rinse

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 · 4

  • ndc11
    5857805171
    1 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLE
  • ndc11
    5857805172
    2 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLE
  • ndc11
    5857805173
    3 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLE
  • ndc11
    5857805174
    946 mL in 1 BOTTLE (58578-0517-4)

Annotations

UNII (FDA Substance ID)
8ZYQ1474W7
SODIUM FLUORIDE
RxCUI 9873
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate 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": "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": "58578-0517_5b621757-befa-4ce3-920d-b884aca94420",
  "productndc": "58578-0517",
  "dosage_form": "RINSE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "SODIUM FLUORIDE",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "CloSYS Silver Sensitive Mouth Rinse",
  "active_ingred_unit": "g/100mL",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Sodium Fluoride",
  "start_marketing_date": "20230101",
  "active_numerator_strength": ".02"
}

Related drugs

Other records sharing ATC code A01AA51.

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