FDA Approves the First Nonprescription Daily Birth Control Pill (2023)

On July 13, 2023, the U.S. Food and Drug Administration (FDA) approved a norgestrel tablet for nonprescription use to prevent pregnancy — in the agency’s words, “the first daily oral contraceptive approved for use in the U.S. without a prescription.” It is a progestin-only pill (one hormone, no estrogen), and the approval allows it to be sold at drug stores, convenience stores, grocery stores and online without a visit to a prescriber. Every other oral contraceptive stayed prescription-only.

This page reports what the FDA’s own documents and the Federal Register say: what the agency approved and when, what a prescription-to-nonprescription switch is, what the pill is, the advisory-committee review, the evidence the FDA cited, what the label says about use and side effects, who the label says the pill is not for, what the approval does not do, its status as of October 18, 2026, and how it fits other nonprescription actions. No brand or company is named here.

Table of Contents

  1. What the FDA Did
  2. What Changed for People Buying It
  3. What a Prescription-to-Nonprescription Switch Is
  4. The Pill Itself: Norgestrel, a Progestin-Only Pill
  5. The Advisory Committee Review
  6. The Evidence the FDA Cited
  7. What the Label Says About Daily Use, Side Effects and Interactions
  8. Who the Label Says the Pill Is Not For
  9. What the Approval Does Not Do
  10. Dates and Legal Status as of October 18, 2026
  11. How It Fits Other Nonprescription Actions
  12. Primary Documents
  13. Key Research Papers
  14. Connections
  15. Featured Videos

1. What the FDA Did

The FDA news release of July 13, 2023, “FDA Approves First Nonprescription Daily Oral Contraceptive,” states that the agency “approved [a] norgestrel tablet for nonprescription use to prevent pregnancy” and calls it “the first daily oral contraceptive approved for use in the U.S. without a prescription.” The tablet contains 0.075 mg of norgestrel.

The approval was not a brand-new drug. It was a change to an existing approval: the Federal Register describes the application as supplemental new drug application (sNDA) 017031/S-041, a request to move a norgestrel tablet first approved for prescription use into nonprescription (over-the-counter, or OTC) status. A later FDA final rule, published December 26, 2024, records the same fact in its own words: “on July 13, 2023, FDA approved supplemental NDA 017031 … tablet, 0.075 mg, as a nonprescription daily oral contraceptive to prevent pregnancy.”

The director of the FDA’s Center for Drug Evaluation and Research (CDER) at the time said in the release: “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

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2. What Changed for People Buying It

According to the FDA release, the approval “provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.” The agency adds that nonprescription availability “may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider.”

The FDA did not set a launch date or a price. The release states that “the timeline for availability and price of this nonprescription product is determined by the manufacturer.” The FDA’s consumer information page on the tablet (content current as of January 16, 2024) states that nonprescription norgestrel “will be available to consumers in 2024.”

The same page explains why a norgestrel pill had not been on the market at all for years: norgestrel was approved for prescription use in the U.S. in 1973 “but has not been available since 2005 because of the manufacturer’s decision to stop selling the drug for business reasons.”

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3. What a Prescription-to-Nonprescription Switch Is

The FDA’s program page on “Prescription-to-Nonprescription (Rx-to-OTC) Switches” describes the process. A company that holds approval for a prescription drug can ask to change its marketing status to nonprescription through the new drug application (NDA) process. The page describes two types:

The page states that a switch application has to include efficacy and safety data showing the product is safe to use without a prescription, and that “the applicant must provide data that demonstrate consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional,” along with post-marketing safety surveillance data. The FDA lists two kinds of consumer study it has guidance documents for: label comprehension studies (can people understand the Drug Facts label?) and self-selection studies (can people use the label to decide correctly whether the product is right for them?).

The legal test, quoted on the same page from the federal regulation 21 CFR 310.200(b), is that prescription status is “not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use,” and that “the drug is safe and effective for use in self-medication as directed in proposed labeling.” The July 2023 release puts the same standard in plain terms: the applicant must show “that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.”

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4. The Pill Itself: Norgestrel, a Progestin-Only Pill

The FDA’s consumer information page states that the tablet “contains the hormone norgestrel and belongs to the class of medications known as progestins,” and that it “does not contain estrogen.” “Progestin-only” means the tablet contains a progestin and no estrogen; the FDA release describes it as a “progestin-only oral contraceptive pill.”

The release states that “the contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973.” The FDA consumer page adds that nonprescription norgestrel “is not approved in the U.S. for uses other than the prevention of pregnancy.”

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5. The Advisory Committee Review

The FDA asked two of its outside expert panels to review the application together: the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. The notices describe the committees’ general function as providing “advice and recommendations to FDA on regulatory issues.” Each notice also established a public docket for comments — a numbered public file in which comments and documents on a matter are collected, here Docket No. FDA-2022-N-1959.

The committees’ vote and discussion are recorded in meeting materials that were not among the documents read for this page, so no vote count is given here. The approval followed about two months after the meeting.

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6. The Evidence the FDA Cited

Consumer understanding. The FDA release states that “studies showed that consumer understanding of information on the … Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product.”

How well it prevents pregnancy. The FDA consumer page states that, “based on the initial clinical trials of norgestrel tablets, the perfect-use effectiveness rate can be as high as 98%, meaning only 2 in 100 women will become pregnant in a year of use.” It defines perfect use as one tablet every day at the same time with no breaks between packs, plus back-up contraception such as condoms whenever a tablet is missed or taken more than 3 hours late. It also states that typical, real-life effectiveness is lower than perfect use, that nonprescription norgestrel “is expected to be less effective than prescription norgestrel used in clinical trials,” and that it “is very likely to be more effective than other currently available nonprescription contraceptive methods.”

Weight. On whether hormonal pills work less well in people who are overweight, the FDA page states that some studies have suggested somewhat reduced effectiveness for hormonal contraceptives in general, but that “the available data are not clear” on whether pregnancy rates are higher.

The public-health context. The release gives the FDA’s reasoning for why access matters: “Almost half of the 6.1 million pregnancies in the U.S. each year are unintended,” and unintended pregnancies “have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery.” The agency states that nonprescription availability “may help reduce the number of unintended pregnancies and their potential negative impacts.”

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7. What the Label Says About Daily Use, Side Effects and Interactions

Timing. The release states that the pill is taken at the same time every day and that “adherence to daily use at the same time of day is important for the effectiveness” of the product. The FDA consumer page states that one tablet is taken every day at the same time, “even if you are having vaginal bleeding,” and that the drug’s effectiveness is reduced, and pregnancy may occur, if it is not.

Missed doses. The FDA consumer page states that the label gives instructions for a missed dose or for vomiting after a dose, and that keeping pregnancy protection after a missed dose involves back-up contraception, such as condoms, for 48 hours after the missed dose or after vomiting.

Side effects. The release lists the most common side effects as irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. The FDA consumer page also names breast tenderness. The release notes that use “may be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding,” and it states that consumers are to inform a health care provider if they develop repeated vaginal bleeding after sex, or prolonged bleeding or an absence of periods.

Pregnancy checks. The release states that anyone who misses two periods, or misses one period after missing doses, or suspects pregnancy is to take a pregnancy test, and that the pill is discontinued if pregnancy is confirmed.

Interactions. The release states that medicines that interact with the pill “can result in decreased efficacy” of the pill or the other medicine, “potentially resulting in unintended pregnancy.” The FDA consumer page lists the situations in which it says to ask a health care provider or pharmacist before use: taking a prescription drug for seizures, tuberculosis, HIV/AIDS or pulmonary hypertension, or a supplement containing St. John’s wort. It adds that norgestrel may also interact with ulipristal acetate, an emergency contraceptive.

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8. Who the Label Says the Pill Is Not For

The FDA’s documents list these label limits:

The FDA consumer page states that norgestrel “is generally safe for most people who could get pregnant,” with the exceptions above, and points people with questions about their own history to a health care professional.

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9. What the Approval Does Not Do

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10. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: final and in effect. A check of the Federal Register through October 18, 2026 found no FDA document withdrawing or changing the July 2023 approval. One later notice touches the same ingredient but a different product: on March 9, 2026 the FDA withdrew approval of 46 new drug applications whose holders had said the products were no longer marketed (91 FR 11321, FR Doc. 2026-04546, effective April 8, 2026). Its list includes a combined ethinyl estradiol and norgestrel tablet under a separate application (NDA 017802) — not the progestin-only tablet approved for nonprescription use under NDA 017031.

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11. How It Fits Other Nonprescription Actions

The same year’s other switch. Three and a half months earlier, on March 29, 2023, the FDA approved a 4 mg naloxone nasal spray for nonprescription use, the first opioid-overdose reversal medicine sold without a prescription — reported on FDA Approves the First Over-the-Counter Naloxone Nasal Spray (2023). The FDA’s December 2024 final rule names both 2023 approvals side by side.

A new route to nonprescription status. That December 26, 2024 final rule, “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” (89 FR 105288, effective January 27, 2025), created a separate pathway. Under it, a drug “could be marketed without a prescription if an applicant implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of” a licensed practitioner. That rule took effect after the 2023 norgestrel approval, which the FDA based on consumers’ use of the nonprescription label alone.

Insurance coverage questions. On October 4, 2023, the Departments of the Treasury, Labor, and Health and Human Services published a request for information on whether health plans could be required to cover over-the-counter preventive items “without cost sharing and without a prescription by a health care provider” (88 FR 68519). The request cites the July 13, 2023 FDA approval of “a progestin-only birth control pill as the first daily oral contraceptive for use in the United States available without a prescription.”

Other 2023 FDA drug actions affecting reproductive health include the withdrawal of the only drug approved to reduce the risk of preterm birth, reported on FDA Withdraws Approval of the Only Drug for Preventing Preterm Birth (2023), and the breast-density reporting rule on FDA Requires Mammography Reports to Tell Every Patient About Breast Density (2023). The FDA’s later look at a long-standing OTC ingredient is on the 2024 oral phenylephrine page.

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12. Primary Documents

  1. U.S. Food and Drug Administration (2023). FDA Approves First Nonprescription Daily Oral Contraceptive. FDA News Release, July 13, 2023 — fda.gov news release
  2. U.S. Food and Drug Administration. Information page on the nonprescription 0.075 mg oral norgestrel tablet. Postmarket Drug Safety Information for Patients and Providers, content current as of January 16, 2024. (The page’s address carries the brand name, so it is given here as plain text: fda.gov, Drugs › Postmarket Drug Safety Information for Patients and Providers.)
  3. U.S. Food and Drug Administration. Prescription-to-Nonprescription (Rx-to-OTC) Switches. Program page, content current as of May 21, 2026 — fda.gov Rx-to-OTC switches
  4. Food and Drug Administration, HHS (2022). Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments. Federal Register 87:56071, September 13, 2022. Docket No. FDA-2022-N-1959 — FR Doc. 2022-19718
  5. Food and Drug Administration, HHS (2022). Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Postponement of Meeting. Federal Register 87:65070, October 27, 2022. Docket No. FDA-2022-N-1959 — FR Doc. 2022-23379
  6. Food and Drug Administration, HHS (2023). Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments. Federal Register 88:18551–18552, March 29, 2023. Docket No. FDA-2022-N-1959 — FR Doc. 2023-06524
  7. Public docket FDA-2022-N-1959 — regulations.gov FDA-2022-N-1959
  8. Department of the Treasury, Department of Labor, Department of Health and Human Services (2023). Request for Information; Coverage of Over-the-Counter Preventive Services. Federal Register 88:68519, October 4, 2023 — FR Doc. 2023-21969
  9. Food and Drug Administration, HHS (2024). Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Final Rule. Federal Register 89:105288, December 26, 2024. Docket No. FDA-2021-N-0862 — FR Doc. 2024-30261
  10. Food and Drug Administration, HHS (2026). Withdrawal of Approval of 46 New Drug Applications; Notice. Federal Register 91:11321, March 9, 2026. Docket No. FDA-2026-N-1302; FR Doc. 2026-04546. (Its title and address carry company names, so it is given here as plain text.)

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Key Research Papers

  1. Glasier A, Edelman A, Creinin MD, Han L, Matulich MC, Brache V, Westhoff CL, Hemon A (2022). Mechanism of action of norgestrel 0.075 mg a progestogen-only pill. I. Effect on ovarian activity. Contraception 112:37-42 — PubMed PMID: 35351445
  2. Han L, Creinin MD, Hemon A, Glasier A, Chen MJ, Edelman A (2022). Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception. Contraception 112:43-47 — PubMed PMID: 35367204
  3. Glasier A, Edelman A, Creinin MD, Brache V, Westhoff CL, Han L, Chen MJ, Hemon A (2023). The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study. Contraception 117:1-6 — PubMed PMID: 36130667
  4. Sober S, Bradford R, Henrie B, Pradeau S, Guillard H, Laurora I, Glasier A (2024). Evaluation of consumer self-selection of a proposed over-the-counter, progestin-only daily oral contraceptive. Contraception 133:110401 — PubMed PMID: 38431260
  5. Laurora I, Henrie B, Guillard H, Bradford R, Sober S, Glasier A (2024). Evaluation of adherence to a daily progestin-only pill in a simulated over-the-counter setting. Contraception 133:110388 — PubMed PMID: 38431261
  6. Grindlay K, Bradford RD, Pradeau S, Guillard H, Laurora I (2026). Label comprehension study for a proposed over-the-counter progestin-only pill. Contraception 158:111360 — PubMed PMID: 41482072
  7. Rodriguez MI, Burns H, Sheridan R, Edelman AB (2025). Over-the-Counter Oral Contraceptive Use and Initiation of Contraception. JAMA Network Open 8(8):e2527438 — PubMed PMID: 40824637

The first two papers study how a 0.075 mg norgestrel pill works (its effects on ovulation and on cervical mucus); the third tests what happens when doses are deliberately delayed or missed. The fourth, fifth and sixth report the kinds of consumer studies the FDA’s switch page describes — self-selection, actual use (adherence) and label comprehension — for a proposed over-the-counter progestin-only pill. The seventh looks at contraceptive use after the pill became available without a prescription.

PubMed Topic Searches

  1. PubMed: norgestrel progestin-only pill
  2. PubMed: over-the-counter oral contraceptives
  3. PubMed: progestin-only pill effectiveness

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Connections

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