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FDA-ApprovedOral tablet (continuous daily, no placebo pills)

Opill

norgestrel · Perrigo

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Key Facts

Form

Oral tablet (continuous daily, no placebo pills)

Frequency

Once daily at the same time each day

Available Doses

0.075mg

FDA Approval Date

July 13, 2023

Mechanism

Progestin-only pill (mini-pill)

Manufacturer

Perrigo

Cost

Self-Pay

$19.99–$49.99/mo

Available OTC at pharmacies, grocery stores, and online. No prescription, doctor visit, or insurance needed. First FDA-approved OTC daily oral contraceptive in U.S. history.

Side Effects

Side EffectRateSource
Irregular bleeding/spotting20–30%FDA label
Headache8%FDA label
Nausea5%FDA label
Breast tenderness4%FDA label
Dizziness2%FDA label
Abdominal pain2%FDA label

Source: Opill FDA Prescribing Information and clinical trial data

Weight Loss Results

Opill OTC Actual-Use Study

Pearl Index: 2.0 per 100 woman-years (typical OTC use)

12 months · Treatment regimen (ITT)

12 months

Open-label, single-arm study evaluating OTC use without provider guidance in 1,000+ women aged 15–50. Demonstrated that women can safely and effectively self-select and use the product.

How It Works

Opill works primarily by thickening cervical mucus so sperm cannot reach the egg. It also thins the uterine lining. Unlike combination pills, it does not reliably suppress ovulation—timing is critical, and the pill must be taken at the same time every day (within a 3-hour window). Missing a pill or taking it late significantly reduces effectiveness.

Mechanism: Norgestrel is a first-generation progestin that prevents pregnancy primarily by thickening cervical mucus (preventing sperm penetration) and altering the endometrial lining. At this dose, it inconsistently suppresses ovulation (about 50% of cycles), making the cervical mucus mechanism critical. It contains no estrogen, making it suitable for women with estrogen contraindications.

Who It's For

Indication

Contraception (available over-the-counter without prescription)

Anyone seeking accessible, affordable contraception without needing a prescription or doctor visit. Ideal for women who cannot use estrogen (smokers over 35, history of blood clots, migraine with aura, breastfeeding). Requires consistent daily timing—best for people with reliable daily routines.

Food & Water Restrictions

✅ No Restrictions

This medication can be taken at any time of day, with or without food and water.

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Switching

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Cost & Insurance

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Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Clinical trial data referenced comes from published studies and FDA prescribing information. Side effect rates are from specific clinical trials and may not reflect real-world experience. Always consult your healthcare provider before starting, stopping, or switching any medication.