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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

  • ndc11
    6631211020
    20 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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