A retrospective study was conducted to evaluate the variation trend in the incidence and epidemiological characteristics of nonsyndromic cleft lip with or without cleft palate in Chinese population. From 1988 to 1992, data were collected from more than 500 hospital-based units involved in a monitoring program and were analyzed by the National Center for Birth Defects Monitoring. The monitored subjects were the hospitalized births from 28 weeks gestation to a period within 7 days after delivery, which included 3246 408 perinatals and 3766 cases. The total incidence of nonsyndromic cleft lip with or without cleft palate was 11.6/10,000; the total incidence of celft lip alone was 3.8/10,000 and that of cleft lip with cleft palate was 7.8/10,000; no significant variation was noted in the annual incidence from 1988 to 1992. The incidence in males was 13.3/10,000, and 9.5/10,000 in females; there was a significant difference (P < 0.01). Of all the 3766 cases, cleft lip with cleft palate accounted for 67%, unilateral cleft lip 28% and unilateral cleft lip with cleft palate 43%. Left cleft lip and left cleft lip with cleft palate constituted 21% and 29% respectively. The sex-ratio was 1.6:1 for nonsyndromic cleft lip with or without cleft palate. It could be concluded that the incidence of nonsyndromic cleft lip with or without cleft palate showed no variation trend in China. Although no difference was found between urban and rural areas, the susceptibility to the defect was higher in males than in females. Cleft lip with cleft palate was more common than other types. There was a predominance of unilateral defects, of which most were on the left side.