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Data updated: Mar 10, 2026

CHLORHEXIDINE GLUCONATE

CHLORHEXIDINE GLUCONATE
Gastroenterology Approved 1989-10-24
9
Indications
--
Phase 3 Trials
36
Years on Market

Details

Status
Prescription
First Approved
1989-10-24
Routes
DENTAL, TOPICAL
Dosage Forms
SOLUTION, SPONGE, CLOTH

CHLORHEXIDINE GLUCONATE Approval History

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What CHLORHEXIDINE GLUCONATE Treats

1 indications

CHLORHEXIDINE GLUCONATE is approved for 1 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gingivitis
Source: FDA Label

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Key Completed Trials

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Trial Timeline

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.

CHLORHEXIDINE GLUCONATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Chlorhexidine Gluconate Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

CHLORHEXIDINE GLUCONATE Patents & Exclusivity

Latest Patent: Oct 2027

Patents (2 active)

US7935093 Expires Oct 2, 2027
US7427574 Expires Apr 25, 2026
Source: FDA Orange Book

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Data Sources

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