🇺🇸
United States · US · US:66312-110_9cea1cd7-afdc-4ff7-a3a5-6133d15c1230
Oraqix
Orange BookUNIISPLATC C01BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDentsply Pharmaceutical
CountryUS (United States)
ATC codeC01BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11663121102020 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
98PI200987
LIDOCAINE
RxCUI 6387
Orange Book
N021451
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "98PI200987",
"rxcui": "6387",
"inchikey": "NNJVILVZKWQKPM-UHFFFAOYSA-N",
"display_name": "LIDOCAINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "PERIODONTAL",
"spl_meta": {
"b501d239-923b-48b2-82ed-6c5c253a67e2": {
"match": "brand_token",
"title": "ORAQIX (LIDOCAINE AND PRILOCAINE) GEL [DENTSPLY PHARMACEUTICAL]",
"spl_version": "12",
"published_date": "2026-04-22"
}
},
"productid": "66312-110_9cea1cd7-afdc-4ff7-a3a5-6133d15c1230",
"productndc": "66312-110",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "021451",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.5%;2.5%",
"product_no": "001",
"approval_date": "Dec 19, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LIDOCAINE; PRILOCAINE",
"proprietary_name": "Oraqix",
"active_ingred_unit": "mg/g; mg/g",
"application_number": "NDA021451",
"marketing_category": "NDA",
"nonproprietary_name": "lidocaine and prilocaine",
"start_marketing_date": "20040102",
"active_numerator_strength": "25; 25"
}Related drugs
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