Rx strength without the Rx

Opill is approved for use without a prescription and is now available.

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Opill

The most effective contraceptive available without a prescription*1

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Opill® is the first and only FDA-approved daily oral contraceptive for over-the-counter (OTC) use, adding convenience and increasing accessibility for those who need it most.2

Opill package

Nearly 50 years of use and scientific evidence show that progestin-only pills, such as Opill, are safe and effective at preventing pregnancy.2

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Opill's progestin-only, estrogen-free formula is suitable for most** people of reproductive age who want to avoid pregnancy.3,12

*When used as directed.
**Do not use Opill if you have or ever had breast cancer. See Opill label for list of warnings.

Opill does NOT protect individuals from HIV/AIDS or other sexually transmitted diseases.
It is NOT an emergency contraceptive and does not prevent pregnancy after unprotected sex.

Approximately 40 million people are at risk of an unintended pregnancy5,6

Many of those at risk for unintended pregnancy are using less effective contraception.1,4,6 In the US, approximately 5 million people at risk for unintended pregnancy are not using contraception at all. 6 Opill's availability means wider accessibility to safe and effective birth control.

~45%
of pregnancies in the US each year are unintended7

~50%
of women at risk of unintended pregnancy report not using contraception due to barriers to access8

Woman Holding Pregnancy Tester
Woman Holding Opill Package

Did you know?

There is no age restriction to purchase Opill.3

The safety and efficacy of Opill tablets have been established in women of reproductive age. Opill can be used by those under 18 years of age with no need for parental consent.

No examinations or tests are needed before initiating or continuing Opill.4,9

While routine gynecological examinations and screenings remain a priority, there is no need for examinations or tests prior to initiation of progestin-only pills such as Opill.9 ACOG

Opill is committed to supporting healthcare access, education and care

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Access

Ensuring people have unrestricted access to contraception on their terms.

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Education

Empowering and equipping people with the knowledge to be in control of their choices, their contraception and their future.

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Care

Encouraging regular visits with a healthcare provider for routine preventive screenings.

References

1. Trussell J, Aiken ARA, Micks E, Guthrie KA. Efficacy, safety, and personal considerations. In: Hatcher RA, Nelson AL, Trussell J, Cwiak C, Cason P, Policar MS, Edelman A, Aiken ARA, Marrazzo J, Kowal D, eds. Contraceptive technology. 21st ed. New York, NY: Ayer Company Publishers, Inc., 2018.
2. US Food and Drug Administration. FDA approves first nonprescription daily oral contraceptive. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive. Accessed October 13, 2023.
3. US Food and Drug Administration. Opill® label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017031s041lbl.pdf. Accessed October 13, 2023.
4. Curtis KM, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1-66.
5. Centers for Disease Control and Prevention. National Survey of Family Growth 2017-2019. Available at: https://www.cdc.gov/nchs/nsfg/nsfg_2017_2019_puf.htm. Accessed July 26, 2023.
6. Data on file. HRA Pharma. Unpublished analysis of the NSFG data by Pinney Associates 2023.
7. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374(9):843-852.
8. Biggs MA, et al. Unprotected intercourse among women wanting to avoid pregnancy: attitudes, behaviors, and beliefs. Womens Health Issues. 2012;22(3):e311-e318.
9. American College of Obstetricians and Gynecologists. ACOG Committee Opinion Number 788: over-the-counter access to hormonal contraception. Obstet Gynecol. 2019;134(4):e96-e105.
10. Han L, et al. Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception. Contraception. 2022;112:43-47.
11. Glasier A, et al. Mechanism of action of norgestrel 0.075 mg a progestogen-only pill. I. Effect on ovarian activity. Contraception. 2022;112:37-42.
12. Curtis KM, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-104.
13. US Food and Drug Administration. Opill (0.075mg oral norgestrel tablet) information. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information. Accessed October 13, 2023.
14. Raine-Bennett T, et al. Ectopic pregnancy prevention: further evidence of benefits of prescription contraceptives. Contraception. 2022;105:19-25.
15. Frederiksen B, et al. Women’s sexual and reproductive health services: key findings from the 2020 KFF Women’s Health Survey. Available at: https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey. Accessed May 25, 2023.
16. Key K, et al. Challenges accessing contraceptive care and interest in over-the-counter oral contraceptive pill use among Black, Indigenous, and people of color: an online cross-sectional survey. Contraception. 2023;120:109950.
17. Grindlay K, Grossman D. Prescription birth control access among U.S. women at risk of unintended pregnancy. J Womens Health (Larchmt). 2016;25(3):249-254.
18. American College of Obstetricians and Gynecologists. Committee Opinion Number 615: access to contraception. Obstet Gynecol. 2015;125(1):250-255.
19. Power to Decide. Tip sheet: understanding contraceptive deserts. Available at: https://powertodecide.org/what-we-do/information/resource-library/understanding-contraceptive-deserts. Accessed April 26, 2023.
20. Grindlay K, et al. Interest in continued use after participation in a study of over-the-counter progestin-only pills in the United States. Womens Health Rep (New Rochelle). 2022;3(1):904-914.
21. Long M, et al. Interest in using over-the-counter oral contraceptive pills: findings from the 2022 KFF Women’s Health Survey. Available at: https://www.kff.org/womens-health-policy/issue-brief/interest-using-over-the-counter-oral-contraceptive-pills-findings-2022-kff-womens-health-survey. Accessed November 16, 2023..
22. Cheng D, et al. Unintended pregnancy and associated maternal preconception, prenatal and postpartum behavior. Contraception. 2009;79(3):194-198.
23. Dibaba Y, et al. The effects of pregnancy intention on the use of antenatal care services: systemic review and meta-analysis. Reprod Health. 2013;10:50.
24. Lindberg L, et al. Pregnancy intentions and maternal and child health: an analysis of longitudinal data in Oklahoma. Matern Child Health J. 2015;19(5):1087-1096.
25. Mohllajee AP, et al. Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol. 2007;109(3):678-686.
26. Kost K, Lindberg L. Pregnancy intentions, maternal behaviors, and infant health: investigating relationships with new measures and propensity score analysis. Demography. 2015;52(1):83-111.
27. Maxson P, Miranda ML. Pregnancy intention, demographic differences, and psychosocial health. J Womens Health (Larchmt). 2011;20(8):1215-1223.
28. Fellenzer JL, Cibula DA. Intendedness of pregnancy and other predictive factors for symptoms of prenatal depression in a population-based study. Matern Child Health J. 2014;18(10):2426-2436.
29. Abajobir AA, et al. A systemic review and meta-analysis of the association between unintended pregnancy and perinatal depression. J Affect Disord. 2016;192:56-63.
30. Grindlay K, et al. Prescription requirements and over-the-counter access to oral contraceptives: a global review. Contraception. 2013;88(1):91-96.
31. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee. Laboratoire HRA presentations. Available at: https://www.fda.gov/media/167980/download. Accessed June 5, 2023.
32. American Medical Association. AMA urges FDA to make oral contraceptive available over-the-counter. Available at: https://www.ama-assn.org/press-center/press-releases/ama-urges-fda-make-oral-contraceptive-available-over-counter. Accessed November 2, 2023.
33. Society for Adolescent Health and Medicine. SAHM statement: over-the-counter status for oral contraceptives. Available at: https://www.regulations.gov/comment/FDA-2022-N-1959-0557. Accessed November 2, 2023.
34. North American Society for Pediatric and Adolescent Gynecology. NASPAG statement to FDA on over the counter OCPs 2022. Available at: https://naspag.memberclicks.net/assets/docs/NASPAG%20Statement%20to%20FDA%20Over%20the%20Counter%20OCPs.pdf. Accessed October 20, 2023.
35. US Food and Drug Administration. Opill tablets. Prescribing information. Laboratoire HRA Pharma; 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf. Accessed October 13, 2023.