FDA approves OTC Differin Epiduo Gel for acne in patients aged 12 years and older

The FDA has approved Differin Epiduo Acne Gel, a fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5%, for over-the-counter (OTC) use in patients aged 12 years and older, according to a May 22 announcement from Galderma.¹ In the announcement, the company said the switch is intended to provide “wider access to a dermatologist-recommended, prescription-strength treatment” for adolescents and adults with acne.

The decision moves a topical retinoid–benzoyl peroxide combination that has been available by prescription for more than 15 years into the US nonprescription market. For pediatric and primary care clinicians, the change may affect how patients initiate acne treatment before seeking medical care and may require additional counseling on appropriate use, irritation mitigation, and when to escalate therapy.

Differin Epiduo contains adapalene, a third-generation topical retinoid, and benzoyl peroxide, an oxidizing antimicrobial agent with activity against Cutibacterium acnes. Retinoids help normalize follicular keratinization and reduce comedone formation, while benzoyl peroxide reduces bacterial burden and has anti-inflammatory effects. Current acne guidelines support topical retinoids, benzoyl peroxide, and fixed-dose combinations as core treatments for many patients with mild to moderate acne, including adolescents.²

The FDA action was a prescription-to-OTC switch rather than approval of a new molecular entity. Galderma stated that the approval was supported by multiple randomized, controlled phase 3 studies in which adapalene/benzoyl peroxide gel outperformed adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, noninflammatory, and total lesion counts, as well as Investigator Global Assessment success rates.^1,3,4 The company also reported improvement in lesion counts as early as week 1 and up to a 70.3% reduction in inflammatory acne lesions at week 12.¹

In a multicenter, randomized, double-blind study published in 2007, the fixed-dose combination demonstrated greater reductions in acne lesion counts than either active ingredient alone or vehicle, with tolerability findings consistent with topical retinoid and benzoyl peroxide use.³ A later randomized controlled study similarly supported the efficacy of the combination regimen in patients with acne vulgaris.⁴ Common local tolerability concerns with this drug class include dryness, erythema, scaling, burning or stinging, and photosensitivity counseling needs; benzoyl peroxide may also bleach hair or fabrics.

The OTC availability may be particularly relevant because acne commonly begins during adolescence and can be associated with pain, scarring, dyspigmentation, and psychosocial distress. Earlier access to evidence-based topical therapy could reduce reliance on less effective cosmetic regimens or inappropriate topical antibiotic monotherapy. However, clinicians should continue to advise patients that OTC treatment is not a substitute for evaluation when acne is severe, nodulocystic, rapidly scarring, or associated with significant psychosocial impact.

For patients and families, the once-daily combination may simplify treatment compared with separate topical products. That said, nonprescription access may also increase the risk of overuse, concurrent use with multiple irritating products, or premature discontinuation because of expected early irritation. Counseling should include applying a thin layer to acne-prone areas rather than spot treatment alone, using noncomedogenic moisturizer and sunscreen, avoiding simultaneous harsh exfoliants, and allowing several weeks to assess response.

The regulatory scope is limited to the United States and to patients aged 12 years and older. Galderma stated that outside the United States, Epiduo remains prescription only.¹ The company said the OTC product is expected to become available at major retailers in summer 2026.

The main limitation for clinicians interpreting the announcement is that the switch does not introduce new head-to-head evidence against current prescription strategies, such as higher-strength adapalene/benzoyl peroxide, topical clascoterone, oral antibiotics, hormonal therapy, or isotretinoin for appropriate candidates. Future real-world data may clarify how OTC access affects adherence, treatment delays, adverse events, and dermatology referral patterns.

References

1. Galderma receives U.S. FDA approval for Differin Epiduo Acne Gel prescription-to-OTC switch. BusinessWire. Published May 22, 2026. Accessed May 26, 2026. https://www.businesswire.com/news/home/20260522074280/en/Galderma-Receives-U.S.-FDA-Approval-for-Differin-Epiduo-Acne-Gel-Prescription-to-OTC-Switch

2. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30. doi:10.1016/j.jaad.2023.12.017

3. Thiboutot DM, Weiss J, Bucko A, et al. Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study. J Am Acad Dermatol. 2007;57(5):791-799. doi:10.1016/j.jaad.2007.06.006

4. Gollnick HP, Draelos Z, Glenn MJ, et al. Adapalene-benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189. doi:10.1111/j.1365-2133.2009.09209.x