Objective : This study was carried out to investigate the acute toxicity and safety of Insampaedok-san and Fermented Insampaedok-san. Methods : SPF ICR male and female mice were administered orally with Insampaedok-san and Fermented Insampaedok-san. of 0(control group), 1,250, 2,500 and 5,000 mg/kg. After single administration, we daily examined number of deaths, clinical signs, gross findings and changes of body weight for 14 days. Hematological parameters and isolated organ weights were determined after 14 days of administration. Results : No dead animal and no significant changes of body weights were found during experimental period. In addition, no differences were found between control and all of treated groups in clinical signs, organ weights, hematology, and other findings. Conclusions : Insampaedok-san and Fermented Insampaedok-san. did not show any toxic effects and oral $LD_{50}$ values of the extracts was over 5,000 mg/kg in ICR mice.