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United States · US · US:83013-338_425b1a2e-7577-13a7-e063-6394a90aa865

Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast

In shortageUNIISPLATC A01AA51

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHISMILE PTY LTD
CountryUS (United States)
ATC codeA01AA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8301333810
    100 g in 1 TUBE (83013-338-10)

Annotations

UNII (FDA Substance ID)
8ZYQ1474W7
SODIUM FLUORIDE
RxCUI 9873
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Oxybate Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "8ZYQ1474W7",
    "rxcui": "9873",
    "inchikey": "PUZPDOWCWNUUKD-UHFFFAOYSA-M",
    "display_name": "SODIUM FLUORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "425b1a2e-7576-13a7-e063-6394a90aa865": {
      "match": "brand_token",
      "title": "GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST (SODIUM FLUORIDE) GEL [HISMILE PTY LTD]",
      "spl_version": "1",
      "published_date": "2025-11-17"
    }
  },
  "productid": "83013-338_425b1a2e-7577-13a7-e063-6394a90aa865",
  "productndc": "83013-338",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "SODIUM FLUORIDE",
  "shortage_reason": "Sodium Oxybate Solution",
  "shortage_status": "current",
  "proprietary_name": "Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast",
  "active_ingred_unit": "g/100g",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Sodium Fluoride",
  "start_marketing_date": "20251030",
  "active_numerator_strength": ".243"
}

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