ABSTRACT:AimsTo assess smoking cessation rates achieved with nicotine gum and patch in simulated over‐the‐counter (OTC) and actual prescription (Rx) settings.DesignSeparate open‐label studies with gum and patch in OTC and Rx settings.ParticipantsThere were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.InterventionsAll smokers received active nicotine replacement. In the OTC setting, smokers self‐selected doses of nicotine gum (2 or 4 mg Nicorette®) or patch (21, 14 or 7 mg NicoDerm®CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician.MeasurementsBiochemically verified continuous smoking abstinence was assessed at 6 weeks (28‐day abstinence) and 6 months.FindingsOTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05–1.98)] and gum [OR = 2.92 (1.58–5.40)], and remained significant at 6 months for patch [OR = 3.63; (1.74–7.61)] but not gum [OR = 1.37; (0.73–2.58)]. Among OTC gum users, 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch, abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months.ConclusionsSmoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real‐world prescribing conditions.