Over-the-counter medicine
Chloroxylenol
Chloroxylenol is an over-the-counter medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the chloroxylenol FDA label on DailyMed (effective July 10, 2026); every chloroxylenol label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHandwash to help decrease bacteria on the skin
Recommended for repeated use
Forms and strengths
- 0.1 g
- 1 g
- 10.11 g
- 0.003 mg/ml
- 0.005 mg/ml
- 0.15 g/100ml
- 0.2 g/100g
- 0.3 g/100ml
- 0.3 mg/100ml
- 0.35 g/100ml
- 0.45 g/100ml
- 0.5 mg/100ml
Liquid; soap; solution; gel; lotion.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 109 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2021 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 33 through July 30, 2026
What is chloroxylenol used for?
From the label: indications and usageHandwash to help decrease bacteria on the skin
Recommended for repeated use
Source: FDA drug label (MICRELL Antibacterial Ltn Sp), GOJO INDUSTRIES, LLC, effective July 10, 2026 (SPL set 166c0d2c-f15d-4a8e-9760-9cb4e989a628), via openFDA; the full label on DailyMed
Is there a generic for chloroxylenol?
No generic chloroxylenol is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has chloroxylenol been recalled?
The FDA's Enforcement Report lists 3 recalls naming chloroxylenol since 2021: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of chloroxylenol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 30, 2022 | Class III | Woodbine Products Co Inc not a listed maker | Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. |
| March 29, 2021 | Class II | Spartan Chemical Co Inc not a listed maker | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for chloroxylenol?
The FDA Adverse Event Reporting System holds 33 reports that list chloroxylenol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 10 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Chloroxylenol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other