Skip to content

Checked

OTC

Hair Regrowth Treatment

minoxidil · Hair Regrowth Treatment is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by 9 manufacturers.

Type
Over the counter
Drug class
Arteriolar Vasodilator
Route
Topical
Manufacturers
9

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

Drug facts

Generic name
minoxidil
Active ingredients
Minoxidil
Dosage forms
Aerosol, foam, Liquid, Solution
Label holder
Amazon.com Services LLC
FDA application
ANDA075598
Label updated
09/08/2026

Active ingredients

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Uses

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

Directions

  • Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • 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. Flammable: Keep away from fire or flame Do not use if

  • You are a woman
  • Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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 if you have 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 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 4 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do not use

If

  • You are a woman
  • Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other information

  • See hair loss pictures on side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information.
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
  • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
  • Store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

Alcohol, propylene glycol, purified water

Questions?

1-800-719-9260

Forms and strengths

From the FDA NDC Directory · 15 product codes

Dosage formStrengthRouteNDCs
Aerosol, foam5 g/100gtopical2
Aerosol, foam50 mg/gtopical2
Liquid5 g/100mLtopical1
Solution2 g/100mLtopical3
Solution5 g/100mLtopical7

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

15 FDA labels

  • Amazon.com Services LLCShown hereANDA075598 · Label 09/08/2026 · NDC 72288-667Full label
  • Amazon.com Services LLCANDA091344 · Label 08/31/2026 · NDC 72288-674Full label
  • CVS PharmacyANDA091344 · Label 05/08/2026 · NDC 69842-599Full label
  • CVS PharmacyANDA075598 · Label 05/22/2025 · NDC 69842-598Full label
  • CVS PharmacyANDA075357 · Label 04/25/2025 · NDC 69842-797Full label
  • Guangzhou Jianyuan Biological Technology.Co.,Ltd505G(a)(3) · Label 05/24/2026 · NDC 81653-005Full label
  • Kroger CompanyANDA075598 · Label 02/05/2025 · NDC 30142-632Full label
  • Meijer Distribution IncANDA091344 · Label 03/25/2026 · NDC 41250-294Full label
  • Meijer Distribution IncANDA091344 · Label 03/19/2026 · NDC 41250-749Full label
  • Meijer, Inc.ANDA075357 · Label 02/05/2026 · NDC 79481-0070Full label
  • Meijer, Inc.ANDA075598 · Label 02/05/2025 · NDC 41250-428Full label
  • Rite Aid CorporationANDA075598 · Label 10/08/2025 · NDC 11822-1260Full label
  • SafewayANDA075598 · Label 08/20/2024 · NDC 21130-611Full label
  • Walgreen CompanyANDA075598 · Label 07/17/2025 · NDC 0363-0032Full label
  • Walgreen CompanyANDA075357 · Label 02/24/2022 · NDC 0363-0703Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Hair Regrowth Treatment: common questions

What is Hair Regrowth Treatment used for?
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Is Hair Regrowth Treatment a prescription drug?
No. Hair Regrowth Treatment is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Hair Regrowth Treatment?
Yes. Other FDA-listed products with the same active ingredients include Minoxidil (For Men), Minoxidil for Women, Minoxidil, Minoxidil 5% (For Men).
Who makes Hair Regrowth Treatment?
9 manufacturers list Hair Regrowth Treatment with the FDA, including Amazon.com Services LLC, CVS Pharmacy, Guangzhou Jianyuan Biological Technology.Co.,Ltd.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 09/08/2026 · Label text is shown as published by the manufacturer. Not medical advice