Opal by Opalescence Complete

UNIISPLATC A01AA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerUltradent Products, Inc.

CountryUS (United States)

ATC codeA01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5120631301
1 TUBE in 1 CARTON (51206-313-01) / 133 g in 1 TUBE
ndc11
5120631302
12 CARTON in 1 PACKAGE, COMBINATION (51206-313-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

3FTR44B32Q

STANNOUS FLUORIDE

RxCUI 10030

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3FTR44B32Q",
    "rxcui": "10030",
    "inchikey": "ANOBYBYXJXCGBS-UHFFFAOYSA-L",
    "display_name": "STANNOUS FLUORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "DENTAL",
  "spl_meta": {
    "5c3bf8fc-2e8f-4a58-bcbf-e47540072a49": {
      "match": "brand_token",
      "title": "OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]",
      "spl_version": "5",
      "published_date": "2025-06-19"
    }
  },
  "productid": "51206-313_37cb56fb-2de8-0628-e063-6394a90a1b56",
  "productndc": "51206-313",
  "dosage_form": "GEL, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "STANNOUS FLUORIDE",
  "proprietary_name": "Opal by Opalescence Complete",
  "active_ingred_unit": "mg/g",
  "application_number": "M021",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Opal by Opalescence Complete",
  "start_marketing_date": "20241021",
  "active_numerator_strength": "1.1"
}

Related drugs

Other records sharing ATC code A01AA04.

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