Skip to content

Checked

OTC

Minoxidil 5% (For Men)

minoxidil · Minoxidil 5% (For Men) is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by 4 manufacturers.

Type
Over the counter
Drug class
Arteriolar Vasodilator
Route
Topical
Manufacturers
4

to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Drug facts

Generic name
minoxidil
Active ingredients
Minoxidil
Dosage forms
Aerosol, foam
Label holder
Better Living Brands, LLC
FDA application
ANDA218616
Label updated
08/27/2026

Active ingredients

Minoxidil USP 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Uses

To regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Directions

Apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use 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. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Do not use

If you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy 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 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 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all men.

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 4 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.

Other information

Hair growth has been shown in a clinical study of men (mostly white) aged 18 to 49 years who used it for 4 months see hair loss pictures on side of this carton before use, read all information on package and enclosed leaflet keep the package. It contains important information store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Inactive ingredients

Alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol Questions? Call toll-free 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O. BOX 99 PLEASANTON, CA 94566-0009 ‡ 1-888-723-3929 MADE IN INDIA Code: TS/DRUGS/58039/2020

Forms and strengths

From the FDA NDC Directory · 4 product codes

Dosage formStrengthRouteNDCs
Aerosol, foam50 mg/gtopical4

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

4 FDA labels

  • Better Living Brands, LLCShown hereANDA218616 · Label 08/27/2026 · NDC 21130-208Full label
  • Aurohealth LLCANDA218616 · Label 01/22/2026 · NDC 58602-608Full label
  • Kroger CompanyANDA209074 · Label 10/24/2022 · NDC 59450-210Full label
  • Thirty MADISON, Inc.ANDA209074 · Label 04/01/2022 · NDC 71713-091Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Minoxidil 5% (For Men): common questions

What is Minoxidil 5% (For Men) used for?
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Is Minoxidil 5% (For Men) a prescription drug?
No. Minoxidil 5% (For Men) is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Minoxidil 5% (For Men)?
Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil.
Who makes Minoxidil 5% (For Men)?
4 manufacturers list Minoxidil 5% (For Men) with the FDA, including Better Living Brands, LLC, Aurohealth LLC, Kroger Company.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/27/2026 · Label text is shown as published by the manufacturer. Not medical advice