By Fineline Cube 
China’s National Medical Products Administration (NMPA) has approved the switch of ambroxol hydrochloride oral drops from prescription-only to over-the-counter (OTC) status. This decision follows a thorough review and approval process by the regulatory authority.
Regulatory Requirements
Relevant drug marketing authorization holders are required to submit revised labeling for record-filing with their provincial medical products administration departments by April 22, 2026. This ensures that the product information aligns with the updated regulatory status.
Product Indication
Ambroxol oral drops are indicated for individuals suffering from thick, tenacious phlegm that is difficult to expectorate. This makes the product accessible to a broader population without the need for a prescription.
Market Presence
Currently, seven companies hold drug registration certificates for ambroxol hydrochloride oral drops in China. This switch to OTC status may expand market reach and facilitate easier access for consumers in need of this medication.-Fineline Info & Tech