FDA clears Epiduo acne gel for over the counter sale

The US Food and Drug Administration approved a prescription-to-over-the-counter switch for Galderma's Differin Epiduo Acne Gel for patients aged 12 years and older. The once-daily gel, which remains prescription-only outside of the United States, is a fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5%. Clinical data from multiple randomized, controlled phase 3 trials supported the switch, showing that the combination outperformed its individual components and a vehicle gel, delivering up to a 70.3% reduction in inflammatory acne lesions at week 12.

For medical-aesthetic clinics, this regulatory shift changes how you manage retail recommendations and patient acne regimens. Because this dual-action formulation will be directly accessible on drugstore shelves starting in summer 2026, you can save your prescription pad for higher-strength retinoids or oral therapies. Expect patients to ask if their current medical-grade skincare protocols overlap with this newly available retail option. You should prepare your staff to advise patients on how to integrate this specific OTC combination safely without causing retinoid dermatitis or compounding irritation from other active topicals in their home routines.

Source: Patient Care Online, https://www.patientcareonline.com/view/fda-clears-otc-adapalene-benzoyl-peroxide-gel-for-acne-in-patients-12-and-older