Benzydamine Mouth Spray

Form: Mouth Spray

Strength: 0.15%

Reference Brands: Difflam Oral Spray(US)

Category: ENT

Benzydamine mouth spray, marketed as Difflam or Tantum Verde, is approved in the US and EU as an OTC topical agent for oral inflammation and sore throat relief. Regulatory approval requires dossiers including safety, efficacy, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical safety and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe use, and broad availability, helping patients worldwide manage oral inflammation, ulcers, and sore throat symptoms effectively with regionally compliant, high-quality benzydamine formulations.