Checked
RegrowthX Hair Regrowth Treatment Minoxidil
minoxidil · RegrowthX Hair Regrowth Treatment Minoxidil is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by Nimex Group Inc.
- Type
- Over the counter
- Drug class
- Arteriolar Vasodilator
- Route
- Topical
- Manufacturers
- 1
to regrow hair on the top of the scalp (vertex only, see picture on side of carton)
Drug facts
- Generic name
- minoxidil
- Active ingredients
- Minoxidil
- Drug class
- Arteriolar Vasodilator
- Dosage forms
- Solution
- Label holder
- Nimex Group Inc
- FDA application
- ANDA076239
- Label updated
- 10/06/2025
Active ingredients
Minoxidil 5% w/v Purpose Hair regrowth treatment for men
Purpose
Hair regrowth treatment for men
Uses
To regrow hair on the top of the scalp (vertex only, see picture 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. 5% minoxidil topical solution 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 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.
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. 5% minoxidil topical solution 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 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.
Inactive ingredients
Alcohol, Propylene Glycol, Purified Water
Questions?
800-375-0182 Visit Website at regrowthX.com
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| 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
1 FDA label
- Nimex Group IncShown hereANDA076239 · Label 10/06/2025 · NDC 87148-881Full 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
RegrowthX Hair Regrowth Treatment Minoxidil: common questions
- What is RegrowthX Hair Regrowth Treatment Minoxidil used for?
- to regrow hair on the top of the scalp (vertex only, see picture on side of carton)
- Is RegrowthX Hair Regrowth Treatment Minoxidil a prescription drug?
- No. RegrowthX Hair Regrowth Treatment Minoxidil is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as RegrowthX Hair Regrowth Treatment Minoxidil?
- Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil.
- Who makes RegrowthX Hair Regrowth Treatment Minoxidil?
- Nimex Group Inc lists RegrowthX Hair Regrowth Treatment Minoxidil with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 10/06/2025 · Label text is shown as published by the manufacturer. Not medical advice