Benzydamine

Benzydamine and its salts are listed on Canada's Prescription Drug List: Human Use, effective 19 December 2013. The Food and Drug Regulations restrict the sale of prescription drugs to authorized provincial dispensers acting on a verbal or written prescription, subject to section C.01.043.

Benzydamine is listed as Benzydamin in Anlage 1 of the Arzneimittelverschreibungsverordnung. Medicinal products consisting of, prepared from, or containing benzydamine, including its salts or hydrates, may be dispensed only on a medical, dental, or veterinary prescription. This requirement does not apply to mouth-and-throat solutions containing no more than 1.5 mg/ml benzydamine hydrochloride or to lozenges containing no more than 3 mg benzydamine hydrochloride per unit. Section 5 also exempts medicinal products made from Anlage 1 substances or preparations by a homeopathic manufacturing technique when the final-product concentration does not exceed the fourth decimal potency; such products may also be mixed with non-prescription substances or preparations.

Poland's official medicinal-products register records two indefinitely valid Tantum Rosa marketing authorizations containing benzydamine hydrochloride: a 53.2 mg/g powder under permit 00278 and a 1 mg/ml vaginal solution under permit 22943. The permit 22943 record classifies both registered package sizes as OTC, the category Article 23a(1)(1) of the Pharmaceutical Law defines as dispensing without a physician's prescription. This classification applies to these authorized medicinal products and does not establish unrestricted sale of bulk or unformulated benzydamine.

Singapore's National Drug Formulary lists registered Difflam therapeutic products containing benzydamine hydrochloride under registrations SIN13625P, SIN13626P and SIN07411P. SIN13625P and SIN07411P are Pharmacy Only Medicines obtainable from a retail pharmacist without a prescription, while SIN13626P is a General Sale List product obtainable from any retailer. These classifications apply to the registered therapeutic-product formulations and do not establish unrestricted status for bulk benzydamine or other unregistered formulations.

The Thai FDA medicinal-product register classifies Difflam Forte Anti-Inflammatory Throat Spray, an oromucosal solution containing benzydamine hydrochloride 3 mg/mL, as a dangerous drug under marketing authorization 1C 37/61. The authorization was approved on 3 April 2018 and is valid through 12 October 2028. Under Annex B clause 17 of the Ministry of Public Health notification on community pharmacy practice, dangerous drugs supplied to individual recipients must be supplied by the pharmacist on duty with professional instructions.