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Minoxidil
Minoxidil is an arteriolar vasodilator (over-the-counter), made by 7 manufacturers.
- Type
- Over the counter
- Drug class
- Arteriolar Vasodilator
- Route
- Topical
- Manufacturers
- 7
to regrow hair on the top of the scalp (see pictures on side of this carton)
Drug facts
- Name
- Minoxidil
- Active ingredients
- Minoxidil
- Drug class
- Arteriolar Vasodilator
- Dosage forms
- Aerosol, foam, Solution
- Label holder
- Keranique
- FDA application
- ANDA208092
- Label updated
- 08/18/2026
Active ingredients
Minoxidil 5% w/w (without propellant)
Purpose
Hair regrowth treatment for women
Uses
To regrow hair on the top of the scalp (see pictures on side of this carton)
Directions
See enclosed leaflet for complete directions on how to use apply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands well using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Warnings
For external use only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. Do not use if your degree of hair loss is different than that shown on the side of this carton because this product may not work for you you have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not use more than directed do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 3 months with once daily use For some women, you may need to use this product once a day for at least 6 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all women. Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 6 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Do not use
If your degree of hair loss is different than that shown on the side of this carton because this product may not work for you you have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp
Ask a doctor before use
Heart disease
When using this product
Do not use more than directed do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 3 months with once daily use For some women, you may need to use this product once a day for at least 6 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all women.
Stop use and ask a doctor
Chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 6 months
Pregnancy or breastfeeding
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children
And pets If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Inactive ingredients
Butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol
Questions?
Call toll free 1 -888-237-4131
Forms and strengths
From the FDA NDC Directory · 13 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Aerosol, foam | 50 mg/g | topical | 6 |
| Aerosol, foam | 50 mg/mL | topical | 1 |
| Solution | 2 g/100mL | topical | 2 |
| Solution | 5 g/100mL | topical | 3 |
| Solution | 50 mg/mL | topical | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 44,659 reports that list minoxidil, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Adverse drug reaction8,585
- Drug ineffective7,760
- Alopecia3,801
- Application site pruritus2,926
- Off label use2,275
- Overdose1,461
- Application site irritation1,420
- Application site pain1,413
- Hair texture abnormal1,409
- Headache1,342
To report a side effect, use FDA MedWatch.
Manufacturers and labels
13 FDA labels
- KeraniqueShown hereANDA208092 · Label 08/18/2026 · NDC 70550-116Full label
- H E BANDA075598 · Label 05/13/2024 · NDC 37808-833Full label
- L. Perrigo CompanyANDA091344 · Label 04/10/2024 · NDC 0113-5129Full label
- P & L Development, LLCANDA208092 · Label 08/06/2026 · NDC 59726-125Full label
- P & L Development, LLCANDA208092 · Label 03/03/2026 · NDC 59726-151Full label
- P & L Development, LLCANDA208092 · Label 03/03/2026 · NDC 59726-122Full label
- P & L Development, LLCANDA208092 · Label 11/05/2024 · NDC 59726-116Full label
- P & L Development, LLCANDA208092 · Label 11/05/2024 · NDC 59726-115Full label
- Publix Super Markets IncANDA075357 · Label 08/12/2025 · NDC 56062-070Full label
- Publix Super Markets IncANDA075598 · Label 08/12/2025 · NDC 56062-322Full label
- THIRTY MADISON INCANDA075598 · Label 05/20/2025 · NDC 71713-094Full label
- WalgreensANDA074588 · Label 05/21/2025 · NDC 0363-9970Full label
- WalgreensANDA075518 · Label 01/28/2025 · NDC 0363-9973Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrug02/01/2023Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.Pharmacy Innovations · Lack of Assurance of Sterility: FDA inspection revealed insanitary...
- Class IIDrug08/05/2020Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15...MasterPharm LLC · 4 products · Lack of Processing Controls (lack of assurance of conformity to...
- Class IDrug07/08/2020Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug...MasterPharm LLC · Super-potent Drug: This recall has been initiated due to the...
- Class IIDrug03/22/2017MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena...Synergy Rx · Lack of Assurance of Sterility: There are also CGMP Deviations.
- Class IIDrug07/20/2016MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACYMedaus, Inc. · Lack of Assurance of Sterility
Minoxidil: common questions
- What is Minoxidil used for?
- to regrow hair on the top of the scalp (see pictures on side of this carton)
- Is Minoxidil a prescription drug?
- No. Minoxidil is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Minoxidil?
- Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil 5% (For Men).
- Who makes Minoxidil?
- 7 manufacturers list Minoxidil with the FDA, including Keranique, H E B, L. Perrigo Company.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/18/2026 · Label text is shown as published by the manufacturer. Not medical advice