Quick answers
- What is Norelgestromin and ethinyl estradiol used for?
- The FDA-approved label (Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., April 16, 2026) says: “Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Norelgestromin and ethinyl estradiol?
- The “Adverse Reactions” section of the FDA label (Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., April 16, 2026) begins: “The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.3)] Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Norelgestromin and ethinyl estradiol?
- The “Drug Interactions” section of the FDA label (Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., April 16, 2026) begins: “Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Norelgestromin and ethinyl estradiol have a boxed warning?
- Yes. The FDA label for Norelgestromin and Ethinyl Estradiol has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Norelgestromin and ethinyl estradiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Norelgestromin and ethinyl estradiol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Norelgestromin and ethinyl estradiol?
- 9 companies list prescription products of Norelgestromin and ethinyl estradiol in the FDA NDC Directory, including Mylan Pharmaceuticals Inc., Zydus Pharmaceuticals USA Inc. and AvKARE.
What Norelgestromin and ethinyl estradiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. …
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (patch, transdermal), Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
7 of 8 FDA labels for this medicine have a boxed warning.
Norelgestromin and ethinyl estradiol boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI |GTE 30 kg/m2
- Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
Read more of this section
For this reason, CHCs, including norelgestromin and ethinyl estradiol transdermal system, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)].
- Contraindicated in Women with a BMI ≥ 30 kg/m 2 Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with a BMI ≥ 30 kg/m 2. The risk of VTE may be greater with norelgestromin and ethinyl estradiol transdermal in women with a BMI ≥ 30 kg/m 2 compared to women with a lower BMI [see Contraindications (4) and Warnings and Precautions (5.1)]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 See full prescribing information for complete boxed warning. ● Norelgestromin and ethinyl estradiol transdermal is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. (4, 5.1) ● Norelgestromin and ethinyl estradiol transdermal is contraindicated for use in women with a BMI ≥ 30 kg/m 2. Women with a BMI ≥ 30 kg/m 2 who use norelgestromin and ethinyl estradiol transdermal may have a higher risk of venous thromboembolic events compared with women with a lower BMI. (4, 5.1, 8.8)
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. Read the full label on DailyMed →
Norelgestromin and ethinyl estradiol side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.3)] Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to norelgestromin and ethinyl estradiol transdermal system in 3330 sexually active women (3322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%). The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability. Adverse drug reactions reported by ≥ 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in these trials are shown in Table 3.
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. This is part of the section. Read the full label on DailyMed →
Norelgestromin and ethinyl estradiol drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs.
Read more of this section
(7.1) 7.1 Effects of Other Drugs on Combined Hormonal Contraceptives Substances Decreasing the Plasma Concentrations of CHCs and Potentially Diminishing the Efficacy of CHCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances Increasing the Plasma Concentrations of CHCs Co-administration of atorvastatin or rosuvastatin and certain CHCs containing EE increase AUC values for EE by approximately 20% to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). 7.2 Effects of Combined Hormonal Contraceptives on Other Drugs CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. This is part of the section. Read the full label on DailyMed →
Norelgestromin and ethinyl estradiol dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
To achieve maximum contraceptive effectiveness, norelgestromin and ethinyl estradiol transdermal system must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling. Norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is patch-free.
Read more of this section
(2.1, 2.3) Apply each new patch on the same day of the week. Wear only one patch at a time. (2.1) Do not cut or alter the patch in any way. (2.1) 2.1 How to Use Norelgestromin and Ethinyl Estradiol Transdermal System The norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 total days). Week 4 is patch-free. Withdrawal bleeding is expected during this time. Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. Do not cut, damage or alter the norelgestromin and ethinyl estradiol transdermal system patch in any way. If the norelgestromin and ethinyl estradiol transdermal system patch is cut, damaged or altered in size, contraceptive efficacy may be impaired. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles. 2.2 How to Start Using Norelgestromin and Ethinyl Estradiol Transdermal System There are multiple options for starting the Norelgestromin and Ethinyl Estradiol transdermal system, and the woman should choose the option that is most appropriate (see Table 1): Table 1: Instructions for Administration Starting Norelgestromin and Ethinyl Estradiol Transdermal System in women with no current use of hormonal contraception The woman has two options for starting the patch and she should choose the option that is right for her: First Day Start The woman should apply her first patch during the first 24 hours of her menstrual period. If a patch is applied after the first 24 hours of menstruation, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) is needed for the first 7 days of the first cycle only. The woman should apply a new patch each week for three weeks (21 total days). Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. No patch is worn during Week Four (the "Patch-Free Week"). Withdrawal bleeding is expected during this time. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles. Sunday Start The woman should apply her first patch on the first Sunday after her menstrual period begins.
Table from the label
| • The woman should tear open the pouch at the edge. She should gently remove the contents of the foil pouch and discard the additional piece of film above the patch. | |
|---|---|
| • The woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers. | |
| • The woman should apply the sticky side of the patch on the skin she has cleaned and dried. She should then remove the other half of the clear plastic and attach the entire patch to her skin. | |
| • The woman should press firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. • She should run her fingers over the entire surface area to smooth out any "wrinkles" around the outer edges of the patch. |
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. This is part of the section. Read the full label on DailyMed →
Norelgestromin and ethinyl estradiol in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy.
Read more of this section
The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. Read the full label on DailyMed →
Norelgestromin and ethinyl estradiol and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
The effects of norelgestromin and ethinyl estradiol transdermal system in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.
Read more of this section
Small amounts of contraceptive steroids and/or metabolites are present in breast milk.
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. Read the full label on DailyMed →
When Norelgestromin and ethinyl estradiol should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: ● At high risk of arterial or venous thromboembolic events.
Read more of this section
Examples include women who: ○ Smoke, if over age 35 [see Boxed Warning, and Warnings and Precautions (5.1)] ○ Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] ○ Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] ○ Have cerebrovascular disease [see Warnings and Precautions (5.1)] ○ Have coronary artery disease [see Warnings and Precautions (5.1)] ○ Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] ○ Have uncontrolled hypertension [see Warnings and Precautions (5.5)] ○ Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)] ○ Have headaches with focal neurological symptoms or have migraine headaches with aura ■ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.8)] ● Body Mass Index ≥ 30 kg/m 2 [see Warnings and Precautions (5.1)] ● Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] ● Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)] ● Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)] ● Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.12)] ● Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations [see Warnings and Precautions (5.4)] At high risk of arterial or venous thromboembolic events (4) BMI ≥ 30 kg/m 2 (4) Breast cancer or other estrogen- or progestin-sensitive cancer (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4)
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. Read the full label on DailyMed →
Norelgestromin and ethinyl estradiol overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in women. In case of suspected overdose, all norelgestromin and ethinyl estradiol transdermal system patches should be removed and symptomatic treatment given.
— FDA label: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026. Read the full label on DailyMed →
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ethinyl estradiol 35 ug/d · norelgestromin 150 ug/d patch | Generic | $31.99–$37.12 per patch 2 packages, lowest to highest |
| ethinyl estradiol 35 ug/mg · norelgestromin 150 ug/mg patch | Generic | $31.32 per patch |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mylan Pharmaceuticals Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- AvKARE1 product
- Viatris Specialty LLC1 product
- A-S Medication Solutions1 product
- Amneal Pharmaceuticals NY LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Bryant Ranch Prepack1 product
- Zydus Lifesciences Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA219990 GWYN LO | Viatris Specialty | July 28, 2026 | — |
Generic approvals (3)
- ANDA200910Mylan Technologies · April 16, 2014
- ANDA213950Amneal · February 25, 2021
- ANDA214594Zydus Pharms · September 14, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1534809, 1536586, 2531285 |
|---|---|
| SPL set ID of the quoted label | 10fa1458-c8ed-4197-922a-1ba7271d2b02 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA219990, 3 ANDA |
| Active ingredients (FDA) | ETHINYL ESTRADIOL / NORELGESTROMIN |
Next steps
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- AvKAREMaker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., effective April 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →