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Data updated: Mar 10, 2026

ORAQIX

LIDOCAINE
Gastroenterology Approved 2003-12-19
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-12-19
Routes
PERIODONTAL
Dosage Forms
GEL

Companies

DENTSPLY PHARM
Active Ingredient: LIDOCAINE , PRILOCAINE

ORAQIX Approval History

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What ORAQIX Treats

6 indications

ORAQIX is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pain
  • Soreness
  • Burning
  • Itching
  • Hemorrhoids
  • Anorectal Discomfort
Source: FDA Label

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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ORAQIX FDA Label Details

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Indications & Usage

FDA Label (PDF)

For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

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Data Sources

FDA Approval: NDA021451 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.