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United States · US · US:85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

In shortageUNIISPLATC A01AA51

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

Identification

ManufacturerYangzhou ONE & ONLY Personal Care Products Co., LTD
CountryUS (United States)
ATC codeA01AA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    8516200301
    144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE
  • ndc11
    8516200302
    5 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE
  • ndc11
    8516200303
    144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE
  • ndc11
    8516200304
    72 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE
  • ndc11
    8516200305
    144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE
  • ndc11
    8516200306
    480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE
  • ndc11
    8516200307
    72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE
  • ndc11
    8516200308
    144 TUBE in 1 BOX (85162-003-08) / 120 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 Acetate 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",
  "spl_meta": {
    "e65fa41e-ce2e-53e4-e053-2995a90a24d2": {
      "match": "brand_token",
      "title": "PLAK SMACKER (STANNOUS FLUORIDE) GEL [YOUNG INNOVATIONS, INC.]",
      "spl_version": "3",
      "published_date": "2025-11-17"
    }
  },
  "productid": "85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08",
  "productndc": "85162-003",
  "dosage_form": "PASTE, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "SODIUM FLUORIDE",
  "shortage_reason": "Sodium Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth",
  "active_ingred_unit": "g/100g",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "SODIUM FLUORIDE",
  "start_marketing_date": "20250116",
  "active_numerator_strength": ".1"
}

Related drugs

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