This study examines the acute toxicity of Monizen® forte when administered to white male mice through intragastric and subcutaneous routes. The evaluation of acute toxicity parameters for MONIZEN® forte was performed at the pharmacology and toxicology laboratory and vivarium of VNIIVSGE, affiliated with the FGBNU FNC VIEW RAN. The toxicological testing followed the protocol outlined in the “Guidelines for conducting preclinical studies of drugs. Part one” (2012).The median lethal dose (LD50) of MONIZEN® forte was found to be 2524 ± 91.5 mg/kg for subcutaneous injection in white nonlinear mice, whereas the oral (intragastric) administration showed an LD50 of 953.82 ± 156 mg/kg. According to the acute toxicity results in mice after a single intragastric dose, MONIZEN® forte is categorized as a moderately toxic compound under the 3rd hazard class in line with the hygienic classification GOST 12.1.007-76. Administering doses higher than recommended via either oral or parenteral routes caused toxic effects on the liver and kidneys in the tested mice.