🇺🇸
United States · US · US:51206-312_37cbe83e-8ca1-40c6-e063-6394a90a1886
Opal by Opalescence Original
In shortageUNIISPLATC A01AA51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUltradent Products, Inc.
CountryUS (United States)
ATC codeA01AA51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1151206312011 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE
- ndc1151206312023 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 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 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": "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": "51206-312_37cbe83e-8ca1-40c6-e063-6394a90a1886",
"productndc": "51206-312",
"dosage_form": "GEL, DENTIFRICE",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "SODIUM FLUORIDE",
"shortage_reason": "Sodium Bicarbonate Injection",
"shortage_status": "current",
"proprietary_name": "Opal by Opalescence Original",
"active_ingred_unit": "mg/g",
"application_number": "M021",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Sodium Fluoride",
"start_marketing_date": "20231119",
"active_numerator_strength": "1.1"
}Related drugs
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