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Opill

norgestrel · Tablet

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Opill
Generic name
norgestrel
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
L. Perrigo Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
5
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Norgestrel .075 mg/1 203717 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
7

Regulatory status

Source: Drugs@FDANDC Directory
Application number
017031
Application type
NDA · New Drug Application
Approval date
October 23, 1973
Sponsor
LABORATOIRE HRA
Products on application
1
Submissions recorded
27
Products approved under application 017031.
Product Trade name Form Strength Ingredient Status TE Flags
017031-001 OPILL TABLET NORGESTREL Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Regulatory exclusivity periods.
Code Expires Product
RTO July 13, 2026 001

Approval history

Source: Drugs@FDA
Most recent submissions on application 017031.
Type No. Action Status Date Review
Supplement 44 Labeling Approved September 24, 2025 Standard
Supplement 43 Labeling Approved March 11, 2024 Standard
Supplement 42 Labeling Approved March 11, 2024 Standard
Supplement 41 Efficacy Approved July 13, 2023 Standard
Supplement 36 Labeling Approved August 15, 2017 Standard
Supplement 35 Labeling Approved August 15, 2017 Standard
Supplement 34 Labeling Approved July 20, 2004 Standard
Supplement 31 Manufacturing (CMC) Approved March 6, 2002 Standard
Supplement 30 Manufacturing (CMC) Approved July 8, 1998 Standard
Supplement 27 Labeling Approved January 18, 1996 Standard
Supplement 26 Labeling Approved November 29, 1994 Standard
Supplement 25 Manufacturing (CMC) Approved January 21, 1993 Standard
Supplement 24 Labeling Approved August 19, 1992 —
Supplement 23 Manufacturing (CMC) Approved October 6, 1988 Standard
Supplement 22 Manufacturing (CMC) Approved September 1, 1988 Standard
Supplement 20 Manufacturing (CMC) Approved April 7, 1987 Standard
Supplement 19 Labeling Approved October 16, 1985 —
Supplement 18 Labeling Approved May 3, 1984 —
Supplement 17 Labeling Approved December 22, 1983 —
Supplement 15 Manufacturing (CMC) Approved June 3, 1982 Standard
Supplement 11 Manufacturing (CMC) Approved April 15, 1980 Standard
Supplement 7 Labeling Approved November 20, 1978 —
Supplement 4 Labeling Approved December 8, 1977 —
Supplement 6 Manufacturing (CMC) Approved August 15, 1977 Standard
Supplement 3 Manufacturing (CMC) Approved December 1, 1976 Standard
Supplement 2 Manufacturing (CMC) Approved January 15, 1976 Standard
Original application 1 Type 3 - New Dosage Form Approved October 23, 1973 Standard

Review documents

  • 0 · Supplement · September 26, 2025
  • 0 · Supplement · September 26, 2025
  • Environmental Assessment · Supplement · August 20, 2024
  • 0 · Supplement · March 12, 2024
  • 0 · Supplement · March 12, 2024
  • 0 · Supplement · July 13, 2023
  • 0 · Supplement · July 13, 2023
  • 0 · Supplement · July 13, 2023
  • 0 · Supplement · July 13, 2023
  • 0 · Supplement · August 29, 2017
  • 0 · Supplement · August 29, 2017
  • 0 · Supplement · August 16, 2017
  • 0 · Supplement · August 16, 2017
  • 0 · Supplement · July 21, 2004

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250127). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250127

Indications and Usage

openFDA Drug Labeling

Use To prevent pregnancy

Purpose Daily Oral Contraceptive

Dosage and Administration

openFDA Drug Labeling

Directions • take 1 tablet at the same time every day • this product will work best to prevent pregnancy when taken exactly as directed • you can start on any day of the month • use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start working See the enclosed leaflet for more information on how to switch from another contraceptive method. • never skip your daily tablet • to prevent pregnancy, take this product every day, even when you bleed or have spotting • when you finish this pack, start the next one the following day without a break • if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days: • take 1 tablet immediately, as soon as you remember that you missed it • then go back to taking your daily tablet at your usual time • use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again • if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed • you should continue to see your healthcare provider(s) for routine healthcare visits When to use a condom (or another barrier method) • every time you have sex for the next 2 days (48 hours): • after you start your first pack of this product • if you take a tablet more than 3 hours late or miss a tablet on 1 or more days • if you vomit or have a severe diarrhea within 4 hours of taking a tablet

Warnings Allergy alert: Do not use if you are allergic to this product or any of its ingredients, such as FD&C yellow No. 5 (tartrazine). People allergic to aspirin often have a tartrazine allergy too. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs. Do not use • if you have or ever had breast cancer • if you are already pregnant or think you may be pregnant • together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device) • as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex • if you are male Ask a doctor before use if • you currently have vaginal bleeding between your periods and you have not already talked to a doctor • you have liver problems • you have or ever had any cancer Ask doctor or pharmacist before use if • you are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, pulmonary hypertension • you are taking a supplement containing St John’s Wort (an herbal ingredient) • if you have taken ulipristal acetate (an emergency contraceptive, or morning after pill) in the past 5 days See the enclosed leaflet for a detailed list of medicines that may interact with this product. When using this product • you are likely to experience changes in your menstrual periods, such as irregular periods, spotting or bleeding between your periods, or you may stop having periods. To prevent pregnancy, keep taking the product. • you may experience headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating • talk to a doctor (but continue taking every day) if • you have repeated vaginal bleeding brought on by sex • you start having periods that last more than 8 days or are unusually heavy • you start having migraines with aura (headaches that start with changes in vision) or your migraine headaches get worse • take a pregnancy test or talk to a doctor if • your period is late after missing any tablets in the last month • you have not had a period for 2 months or think you may be pregnant Seek medical help right away if • you have sudden or severe persistent pain in your lower belly mostly on one side (you could have an ectopic pregnancy) • you develop yellowing of your skin or whites of your eyes especially with fever, tiredness, loss of appetite or dark colored urine Stop use and ask a doctor if • you become pregnant Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use • if you have or ever had breast cancer • if you are already pregnant or think you may be pregnant • together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device) • as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex • if you are male

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if • you currently have vaginal bleeding between your periods and you have not already talked to a doctor • you have liver problems • you have or ever had any cancer

Stop use and ask a doctor if • you become pregnant

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Norgestrel 0.075 mg

Adverse event reports

Source: openFDA FAERS
2,254
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: NORGESTREL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0113-8101-01 0113-8101 L. Perrigo Company 1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK March 4, 2024
0113-8101-03 0113-8101 L. Perrigo Company 3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK March 4, 2024
0113-8101-04 0113-8101 L. Perrigo Company 4 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK March 22, 2024
0113-8101-06 0113-8101 L. Perrigo Company 6 BLISTER PACK in 1 CARTON (0113-8101-06) / 28 TABLET in 1 BLISTER PACK March 4, 2024
67296-1938-2 67296-1938 Redpharm Drug 1 BLISTER PACK in 1 CARTON (67296-1938-2) / 28 TABLET in 1 BLISTER PACK March 4, 2024
0113-8101 0113-8101 L. Perrigo Company — March 4, 2024
67296-1938 67296-1938 Redpharm Drug — March 4, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.