Product Dossier

DIFFLAM

Product Dossier for DIFFLAM (Glycyrrhiza glabra root Extract dry concentrate, menthol, Phyllanthus emblica fruit Extract dry concentrate, Zingiber…

What it is

DIFFLAM is a brand of therapeutic products sponsored by iNova Pharmaceuticals. The brand encompasses multiple formulations addressing sore throat, mouth irritation and related symptoms, with variants including gels, sprays, lozenges, and gargle solutions available across the Australian market.

Approved indications

DIFFLAM products are indicated for sore throat and mouth conditions. The specific indications vary by formulation: — Anti-inflammatory relief for sore throat and mouth — Antiseptic and anti-inflammatory relief for sore throat and mouth — Antibacterial and anti-inflammatory relief for sore throat and mouth — Anaesthetic, antibacterial and anti-inflammatory relief for sore throat — Antibacterial gargle for sore throat

Dosing overview

DIFFLAM is available in multiple formulations and strengths. Gel formulations are supplied at 30 mg/g and 50 mg/g concentrations. Sprays are available at 1.5 mg/mL and 3 mg/mL strengths. Lozenges are provided in multiple flavours. Solution and gargle formulations include benzydamine hydrochloride at 1.5 mg/mL and povidone-iodine at 10 mg/mL and 75 mg/mL concentrations.

Key safety warnings

Specific safety warnings for individual DIFFLAM formulations are not detailed in the available source documents.

Contraindications

Specific contraindications for DIFFLAM formulations are not detailed in the available source documents.

PBS listing

DIFFLAM mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL (500 mL bottle) is listed on the PBS as 3 items with streamlined restriction. The ex-manufacturer price is A$8.10.

Regulatory history

DIFFLAM gel formulations (30 mg/g and 50 mg/g) were first registered on the ARTG on 16 July 1991. The sore throat and mouth solution was registered on 1 June 1992, followed by the DIFFLAM PLUS sore throat and mouth solution on 14 December 1992. Subsequent registrations included mouth gel formulations in 1994, lozenges from 1995 onwards, and spray formulations commencing in 2000. The DIFFLAM SORE THROAT SPRAY ANTI-INFLAMMATORY FORTE (3 mg/mL) was registered on 12 November 2004. Iodine-based formulations were added to the product range in 2008 and 2010. DIFFLAM PLUS formulations with anaesthetic, antibacterial and anti-inflammatory properties were introduced from 2013 onwards. A triple-action spray combining anaesthetic, antibacterial and anti-inflammatory ingredients was registered on 20 August 2019. DIFFLAM KIDS 6 YEARS+ SORE THROAT SPRAY was registered on 20 February 2025.