In July 2023, the U.S. Food and Drug Administration approved norgestrel (Opill) as the first over-the-counter oral contraceptive pill available in the United States. Norgestrel is indicated specifically for the prevention of pregnancy, contains only progesterone, and is indicated for daily oral use.
January 8, 2025

Birth Control Without a Prescription

Evidence-Based Over-The-Counter Guide

William Shen

William Shen

Co-founder & CPO

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In July 2023, the U.S. Food and Drug Administration approved norgestrel (Opill) as the first over-the-counter oral contraceptive pill available in the United States. Norgestrel is indicated specifically for the prevention of pregnancy, contains only progesterone, and is indicated for daily oral use. 


Only over-the-counter option: 

  • Norgestrel. Dose: 0.075 mg orally once daily within a 3 hour window. Failure rate: perfect use 0.3%, typical use 9%. Norgestrel 0.075 mg tablets (NDA 17031/S-041).

Prescription medications & interventions: 

  • Combined oral contraceptives include estrogen and can block ovulation

  • Intra-uterine devices can have >99% effectiveness at preventing pregnancy

Citations:

US Food and Drug Administration. (2023). FDA approves first nonprescription daily oral contraceptive.


What OTC evidence is reviewed?

  • For each condition, we performed a literature review to find a recent widely cited expert group guideline published in the leading specialty-specific peer-reviewed journal or top general medical journal.

  • Based on the recommendations in the publication, we identify recommended active ingredients and devices that are available over-the-counter per FDA regulations.

What evidence is prioritized?

Levels of evidence considered:

  • Tier 1 (Safe and Definitely Effective): Professional field consensus or multiple randomized controlled clinical trials showing the same conclusion. Wherever possible, we use Tier 1 evidence for "first-line" recommendations.

  • Tier 2 (Safe and Probably Effective): Individual clinical trials which may be discordant or large-scale observational experience. Tier 2 evidence may inform "first-line", "second-line", or "supplement" recommendations.

  • Tier 3 (Safe and Maybe Effective): Mechanistic plausibility without high-quality clinical evidence of efficacy but high-quality evidence of safety. Tier 3 evidence may inform "second-line" or "supplement" recommendations.

How does MDandMe select recommended products?

  • Based on the top clinical recommendation, we evaluate products containing the recommended active agent with FDA-approved dosage based on price, average customer reviews, how often it is purchased, and how quickly it will ship to home. 

  • We provide public documentation of the active ingredients in our recommendations, using all 32 FDA monographs, Prescription-to-Nonprescription (Rx-to-OTC) Switches, as well as New Drug Application (NDA) approvals.

How does MDandMe select recommended devices?

  • Based on the top clinical recommendation, we evaluate devices that are FDA-cleared or comply with other medical guidelines (if not a FDA-regulated category) by reputability, price, and average customer reviews.

  • We provide public documentation of supporting evidence for each device.  

Where do I view other OTC guides?

Browse topic list here:

You can view all of our published OTC guides here.