Prescription and over-the-counter medicine
Minoxidil Brand names: Rogaine; first approved as Loniten
Minoxidil (Rogaine) is a prescription and over-the-counter medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 86 generic labelers, and pharmacies paid $0.156 per minoxidil 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the minoxidil FDA label on DailyMed (effective September 6, 2024, Kenvue Brands LLC); the NDA 18154 record on Drugs@FDA; every minoxidil label on DailyMed.
Highlights of the record
FDA label of September 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents. In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects (see Cardiac Lesions in Animals ). Minoxidil must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic, frequently one acting in the ascending limb of the loop of Henle, to prevent serious fluid accumulation. Patients with malignant hypertension and those already receiving guanethidine (see WARNINGS ) should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.
This box is printed on the prescription label of minoxidil; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usageto regrow hair on the scalp
Forms and strengths
- 2.5 mg
- 10 mg
- 0.02 g/ml
- 2 g/100ml
- 3 g/60ml
- 5 g/100ml
- 5 g/100g
- 20 mg/ml
- 50 mg/g
- 50 mg/ml
Solution; aerosol (foam); tablet; liquid; spray.
On the market
- Earliest approval on file
- October 18, 1979 Loniten, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 28 first March 3, 1987; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 87 of which 86 under generic applications, 1 under brand applications, repackagers included; 36 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.156 per tablet Minoxidil 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest July 2, 2013
- FAERS reports
- 44,687 through July 30, 2026
What is minoxidil used for?
From the label: indications and usageto regrow hair on the scalp
Conditions named in the indications of minoxidil's FDA labels, with every medicine labeled for each:
From other minoxidil labelsHigh blood pressure: INDICATIONS AND USAGE Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum …
FDA pharmacologic class: Arteriolar Vasodilator.
Source: FDA drug label (Womens Rogaine Unscented), Kenvue Brands LLC, effective September 6, 2024 (SPL set 8bf0000c-95f3-4a4d-830b-f5ac1539823d), via openFDA; the full label on DailyMed
Is there a generic for minoxidil (Rogaine)?
The FDA approved the first generic minoxidil on March 3, 1987. 28 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists minoxidil from 86 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 1987 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for minoxidil (Rogaine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.156 per Minoxidil 10 mg tablet, down 17% from $0.189 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Minoxidil 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Minoxidil 10 mg tablet | Generic | $0.156 per tablet | $4.68 | -17% |
| Minoxidil 2.5 mg tablet | Generic | $0.0982 per tablet | $2.95 | -0.5% |
| Minoxidil 5% solution | Generic | $0.301 per mL | n/a | n/a |
| Minoxidil for men 5% foam | Generic | $0.275 per gram | n/a | n/a |
| Minoxidil for women 5% foam | Generic | $0.275 per gram | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has minoxidil been recalled?
The FDA's Enforcement Report lists 1 recall naming minoxidil since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup:MINOXIDIL, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for minoxidil?
The FDA Adverse Event Reporting System holds 44,687 reports that list minoxidil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 450 are coded as a death and 2,092 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2022 (8,466, against a median of 2,765 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does minoxidil compare with medicines for the same use?
4 side-by-side pages set minoxidil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to minoxidil
- medicines labeled for the same conditions
- Other arteriolar vasodilators
- the pharmacologic class, with prices and generics
- Minoxidil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other