Objective To investigate and analyze the status of pediatric Chinese patent medicines and simple preparations included in the 2025 edition of Chinese Pharmacopoeia (Volume I), in order to provide reference for the rational use of pediatric Chinese patent medicines and simple preparations in clinical practice. Methods Based on the contents contained in the 2025 edition of Chinese Pharmacopoeia (Volume I), the current status of pediatric Chinese patent medicines and simple preparations was systematically analyzed in terms of varieties, dosage forms, efficacy and indications, usage and dosage, and safety information, and the prescription rules of high-frequency drugs were explored. Results The 2025 edition contains 1 616 kinds of traditional Chinese patent medicines and simple preparations, including 100 kinds of traditional Chinese patent medicines and simple preparations for children whose names include "child" and "pediatric", accounting for 6.19%, while in the 2020 edition, there are 53 kinds of Chinese patent medicines and simple preparations for children, so the 2025 edition contains 47 more than the 2020 edition. There are 642 kinds of traditional Chinese patent medicines and simple preparations that can be used for children, and 61 kinds of traditional Chinese patent medicines and simple preparations that should be used with caution or must be prohibited. The main efficacy of traditional Chinese patent medicines and simple preparations for children is cough-relieving and asthma-relieving (21%), and the main dosage form is granules (24%). A majority of the medicines (65%) has usage based on specific age classification, but not many with adverse reactions clarified, accounting for only 26% of specific drugs for children. SPSS Statistics 21.0 and SPSS Modeler 18.0 software were used to conduct systematic cluster analysis and association rule analysis on high-frequency drugs (frequency>10). Four cluster prescriptions were obtained, C1: malt, Shenqu, hawthorn, betel nut, Poria cocos, tangerine peel, Atractylodes macrocephala, Ophiopogon japonicus; C2: Pueraria lobata, buffalo horn, Forsythia suspensa, Isatis root, honeysuckle, Scutellaria baicalensis, Bupleurum chinense, Rheum palmatum, Gardenia jasminoides; C3: bezoar, borneol, musk, Coptis chinensis, cinnabar, peppermint; C4: bitter almond, gypsum, Platycodon grandiflorum, Scrophularia suspensa, Anemarrhena chinensis, Bulbus fritillaria, licorice. Conclusion The development of traditional Chinese patent medicines and simple preparations for children in China has some problems, such as lack of specific varieties, unclear usage and dosage, and non-standard functions and indications. We should encourage R&D and innovation, improve drug standards, strengthen clinical research, strengthen rational drug use guidance and establish a monitoring system and adopt other measures, which can effectively improve the current situation of the use of traditional Chinese patent medicines and simple preparations for pediatric use, improve its safety and effectiveness, and better safeguard children's health.