Over-the-counter medicine
Benzalkonium
Benzalkonium 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 benzalkonium FDA label on DailyMed (effective November 19, 2025); every benzalkonium label on DailyMed.
Highlights of the record
FDA label of November 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKills 99.99% bacteria.
Forms and strengths
- 0.13 g
- 1.3 g
- 1.3 mg
- 0.0013 mg/ml
- 0.005 mg/ml
- 0.1 g/100g
- 0.1 g/100ml
- 0.12 g/100ml
- 0.13 g/100ml
- 0.13 g/100g
- 0.13 g/1001
- 0.13 mg/100ml
Liquid; cloth; solution; soap; swab.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 382 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 2012 2 Class I among all firms' recalls; 22 more by firms not listed as its makers
- FAERS reports
- 471 through July 30, 2026
What is benzalkonium used for?
From the label: indications and usageKills 99.99% bacteria. For handwashing to decrease bacteria on the skin.
Source: FDA drug label (Dial Antibacterial Hydrating Coconut Milk), Henkel Corporation, effective November 19, 2025 (SPL set 43f9be89-b434-75da-e063-6294a90a1864), via openFDA; the full label on DailyMed
Is there a generic for benzalkonium?
No generic benzalkonium is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has benzalkonium been recalled?
The FDA's Enforcement Report lists 22 recalls naming benzalkonium since 2012: 2 Class I (the most serious), 20 Class II, 0 Class III; 16 still ongoing. 22 of them are by firms that FDA's NDC Directory does not list as a maker of benzalkonium 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 |
|---|---|---|---|
| April 8, 2026 | Class I | Blaine Labs Inc not a listed maker | Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp |
| April 8, 2026 | Class II | Blaine Labs Inc not a listed maker | CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated |
| April 8, 2026 | Class II | Blaine Labs Inc not a listed maker | CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated |
| January 20, 2026 | Class II | ACME UNITED CORPORATION not a listed maker | CGMP Deviations |
| January 25, 2022 | Class I | Blaine Labs Inc not a listed maker | Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. |
| March 29, 2021 | Class II | Spartan Chemical Co Inc not a listed maker | CGMP Deviations |
| November 9, 2018 | Class II | Ecolab Inc not a listed maker | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. |
| October 26, 2018 | Class II | S.C. Johnson Professional not a listed maker | CGMP Deviations: Product was released to market prior to microbiological testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the benzalkonium label say about other medicines?
The benzalkonium label names no other medicine on this site. The labels of 18 other medicines name benzalkonium. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name benzalkonium
Source: FDA drug label (Dial Antibacterial Hydrating Coconut Milk), Henkel Corporation, effective November 19, 2025 (SPL set 43f9be89-b434-75da-e063-6294a90a1864), via openFDA; the full label on DailyMed
What do FAERS reports show for benzalkonium?
The FDA Adverse Event Reporting System holds 471 reports that list benzalkonium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 214 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?
- Benzalkonium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other