Sodium Chloride Nasal Spray

Form: Spray

Strength: 0.9%

Reference Brands: Ocean, Simply Saline, Ayr, NeilMed(US)

Category: ENT

Sodium chloride nasal spray is regulated as a medical device or a cosmetic product in the US by the FDA and in the EU via EMA as a nasal hygiene product. Approval requires dossiers including safety assessments, ingredient sourcing, manufacturing standards, and efficacy data. The FDA reviews compliance with safety and labeling standards, while the EMA ensures regional safety and quality standards. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports timely approval, safe use, and broad worldwide availability, enabling consumers to benefit from drug-free nasal moisturization, congestion relief, and hygiene support across healthcare regions globally.