Checked
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
- Drug class
- Arteriolar Vasodilator
- 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 form | Strength | Route | NDCs |
|---|---|---|---|
| Aerosol, foam | 5 g/100g | topical | 2 |
| Aerosol, foam | 50 mg/g | topical | 2 |
| Liquid | 5 g/100mL | topical | 1 |
| Solution | 2 g/100mL | topical | 3 |
| Solution | 5 g/100mL | topical | 7 |
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
- 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
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