Quick answers
- What is Chlorhexidine gluconate used for?
- The FDA-approved label (Peridex, Solventum US LLC, August 1, 2024) says: “INDICATION: Peridex 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. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chlorhexidine gluconate have a boxed warning?
- No. None of the 48 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Chlorhexidine gluconate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Chlorhexidine gluconate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 1, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Chlorhexidine gluconate?
- 32 companies list prescription products of Chlorhexidine gluconate in the FDA NDC Directory, including Xttrium Laboratories, Inc., Cardinal Health 107, LLC and Atlantic Biologicals Corp..
What Chlorhexidine gluconate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATION: Peridex 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. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
— FDA label: Peridex, Solventum US LLC, effective August 1, 2024. Read the full label on DailyMed →
The FDA has 48 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 48 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Rinse · Solution · Liquid |
|---|---|
| Route | Oral · Dental · Buccal · Topical |
| Prescription products | 53 in the FDA NDC Directory |
| Brand names | Periogard Alcohol Free, Dash Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse, Acclean Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, Nupro Chlorhexidine Gluconate, Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse, Major Oral Rinse, Peridex, Betasept, Antiseptic Skin Cleanser, Sky Oral Rinse |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| chlorhexidine gluconate 1.2 mg/mL rinse | Generic | $0.0081 per mL |
| chlorhexidine gluconate 1.2 mg/mL solution | Generic | $0.0081 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Xttrium Laboratories, Inc.12 products
- Cardinal Health 107, LLC4 products
- Atlantic Biologicals Corp.3 products
- Colgate Oral Pharmaceuticals, Inc.2 products
- Chartwell RX, LLC2 products
- NuCare Pharmaceuticals, Inc.2 products
- Safco Dental Supply LLC2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Rising Pharma Holdings, Inc.2 products
- Brisk Pharmaceuticals1 product
- American Health Packaging1 product
- Bajaj Medical, LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Natco Pharma USA LLC1 product
- Kesin Pharma Corporation1 product
- Solventum US LLC1 product
- A-S Medication Solutions1 product
- McKesson1 product
- VistaPharm, LLC1 product
- Benco Dental1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Den-mat Holdings, LLC1 product
- Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"1 product
- Major Pharmaceuticals1 product
- Atlantic Biologicals Corps1 product
- Sage Products LLC1 product
- Lyne Laboratories, Inc.1 product
- A2A Integrated Pharmaceuticals, LLC1 product
- Proficient Rx LP1 product
- Medline Industries, LP1 product
- Darby Dental Supply, LLC1 product
- Remedyrepack Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019028 PERIDEX | Solventum | August 13, 1986 | 15, latest April 9, 2013 2013: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2013: Labeling |
| NDA019125 DYNA-HEX 4 | Xttrium | December 24, 1984 | 27, latest July 24, 2026 2026: Labeling · 2026: Manufacturing (CMC) · 2022: Manufacturing (CMC) |
Generic approvals (6)
- ANDA074522Pharm Assoc · December 15, 1995
- ANDA074291Lyne · December 28, 1995
- ANDA075561Bajaj · November 14, 2000
- ANDA075006Chartwell Rx · March 3, 2004
- ANDA077789Pharmobedient · June 18, 2009
- ANDA203212Colgate-Palmolive Co · January 28, 2016
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 1, 2017 · Class II · Terminated · D-0938-2017
CGMP Deviations
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16 — Xttrium Laboratories Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Peridex, Solventum US LLC, effective August 1, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →