FDA approves Differin Epiduo Acne Gel for over-the-counter use

The FDA has approved Differin’s Epiduo Acne Gel (adapalene 0.1% and benzoyl peroxide 2.5% acne treatment) for over-the-counter use in patients ages 12 and older, according to a recent news release published by drug manufacturer Galderma. It will be available at most major retailers in the summer of 2026, including Walmart, Ulta and Target.

“This milestone reflects a meaningful advancement for patients, as it expands access to a clinically proven, dual-active acne solution without the need for a prescription,” Heather Woolery-Lloyd, M.D., a dermatologist practicing in North Miami, said in the news release. “In my practice, the combination of easy access and a simple, once-daily application can help patients use treatment more consistently in their treatment journey for the best possible outcomes.”

Acne is the most common skin condition in the United States, affecting up to approximately 50 million people every year, according to the American Academy of Dermatology. It commonly begins during puberty when hormonal changes cause sebaceous glands in the skin to overproduce oil. The excess oil then mixes with dead skin cells, clogs pores and creates an environment for bacteria to thrive.

Because there are many types of acne, including blackheads, whiteheads and pustules, treatment is typically highly individualized, with treatment costs ranging from hundreds of dollars per year to thousands, according to a 2023 review published in Cutis by researchers at Brigham and Women's Hospital and Harvard Medical School. Additionally, 3 in 10 patients reported not taking their medication as prescribed due to cost, with financial barriers linked to reduced adherence and worse outcomes.

Epiduo was previously only available through a prescription, originally approved by the FDA in December 2008. It was the first FDA-approved stable, fixed-dose prescription acne treatment to combine benzoyl peroxide with a retinoid.

Its mechanism of action is the combination of adapalene, a retinoid that reduces inflammation and helps control skin cell growth, and benzoyl peroxide, which kills acne-causing bacteria and removes dead skin cells to help keep pores clear.

Multiple studies have found the combination of adapalene and benzoyl peroxide to be more effective at treating and preventing acne than each ingredient as a standalone treatment. One of the trials, done in 2009, consisting of 1,670 individuals, showed a 70.3% reduction in inflammatory acne lesions by 12 weeks.

Adapalene, in particular, has a well-established safety profile that supported the case for OTC reclassification. Unlike some older retinoids, it is generally well-tolerated, with the most commonly reported side effects being mild dryness, redness, and peeling, particularly during the first few weeks of use as skin adjusts to the treatment.

Dermatologists recommend starting slowly, applying a pea-sized amount every other day for the first one to two weeks before gradually increasing to nightly use. Using a gentle, non-comedogenic moisturizer alongside the gel can help minimize irritation and improve tolerability, especially for those with sensitive skin.

Epiduo Forte (0.3% adapalene and 2.5% benzoyl peroxide) is still available by prescription only, offering a stronger option for patients with more severe or treatment-resistant acne who require closer medical supervision.