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# Topical Xylocaine Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/topical-xylocaine-not-withdrawn-due-to-safety-efficacy/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152317

*Federal Register* notice: FDA has determined that Fresenius Kabi’s Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due to safety or effectiveness issues. The determination allows FDA to approve ANDAs that reference the product as long as relevant legal and regulatory requirements are met. The product is indicated for topical anesthesia of the mucous membranes of the respiratory tract or the genito-urinary tract. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-15594.pdf?ref=fdaweb.com).