The aim of this study was to investigate the acute toxicity and safety of fermented Soshiho-tang extract using male and female ICR mice. Mice were treated with fermented Soshiho-tang extract once orally at 1250, 2500 or 5000 mg/kg and observed for two weeks. At the doses used, no mortality or abnormal clinical signs in animals were shown during at the observation period. In addition, no differences were found between control and treated groups in body weight, hematology and biochemical analysis, and other findings. Above data strongly suggest that no observed adverse effect level of fermented Soshiho-tang extract might be over 5000 mg/kg/day in this study.