NDC 53329-301
Chlorhexidine Gluconate 1.2 mg per 1 mL rinse
On the label: Medline Industries, LP. It's repackaged: Medline Industries, LP rebottles it from Xttrium Laboratories, Inc.'s NDC 0116-2001.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Xttrium Laboratories, Inc. | Mount Prospect, IL, United States | Makes it | Problems found, fixed voluntarilyJun 16, 2026 · 17 inspections, 2 with FDA action |
Recalls
- Jun 1, 2017 · Class II · Xttrium Laboratories Inc
CGMP Deviations
Lots: 1999CHG16MC-Lot number 704-201 (full lot # 704-1999-201), Exp 03/20 1999CHG16MC-Lot number 705-208 (full lot # 705-1999-208), Exp 04/20
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Chlorhexidine: every company that makes it
- Form
- rinse, oral
- Strength
- 1.2 mg per 1 mL
- Approval
- ANDA ANDA077789
- On the market since
- Aug 5, 2010
- Package NDCs
53329-301-2453329-301-3053329-301-61- Official label
- DailyMed (National Library of Medicine), updated Aug 19, 2026
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