Objective : Ssanghwa-tang has been used as herbal medine, favorite beverage or health beverage. This study was performed to evaluate the acute toxity and safety of fermented Ssanghwa-tang extract in ICR mice. Methods : 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 35 male and 35 female ICR mice. After single administration, we observed number of death, clinical signs, changes of body weight for 14 days. After 14 day of administration, all mice were sacrificed and major organ were observed. Results : Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions : These results suggest that Sssanghwa-tang fermented with nuruk extracts might be safe to ICR mice.