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Minoxidil Extra Strength (For Men)
minoxidil · Minoxidil Extra Strength (For Men) is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by 2 manufacturers.
- Type
- Over the counter
- Drug class
- Arteriolar Vasodilator
- Route
- Topical
- Manufacturers
- 2
lndications & usage Uses Uses
Drug facts
- Generic name
- minoxidil
- Active ingredients
- Minoxidil
- Drug class
- Arteriolar Vasodilator
- Dosage forms
- Liquid, Solution, Spray
- Label holder
- FlexiGo Inc
- FDA application
- ANDA075598
- Label updated
- 09/20/2026
Active ingredients
Minoxidil Minoxidil Minoxidil
Purpose
Purpose purpose
Uses
Lndications & usage Uses Uses
Directions
& administraton secion DIRECTIONS DIRECTIONS
Warnings
Warnings Warnings
Do not use
Do not use if do not use if
Ask a doctor before use
Ask a doctor Drug facts Ask a doctor
When using this product
When using the product When using the product When using the product
Stop use and ask a doctor
Stop use and ask a doctor if stop use and ask a doctor if
Keep out of reach of children
KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN
Other information
STORAGE AND HANDLING STORAGE AND HANDLING
Inactive ingredients
Inactive ingredient Inactive ingredient
Questions?
Questions? questions?
Forms and strengths
From the FDA NDC Directory · 3 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Liquid | 5 g/100mL | topical | 1 |
| Solution | 5 g/100mL | topical | 1 |
| Spray | 5 g/100mL | 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
3 FDA labels
- FlexiGo IncShown hereANDA075598 · Label 09/20/2026 · NDC 85524-2614Full label
- Roman Health Ventures Inc.ANDA076239 · Label 01/30/2025 · NDC 72484-097Full label
- Roman Health Ventures Inc.ANDA076239 · Label 01/08/2025 · NDC 72484-095Full 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 Extra Strength (For Men): common questions
- What is Minoxidil Extra Strength (For Men) used for?
- lndications & usage Uses Uses
- Is Minoxidil Extra Strength (For Men) a prescription drug?
- No. Minoxidil Extra Strength (For Men) is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Minoxidil Extra Strength (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 Extra Strength (For Men)?
- 2 manufacturers list Minoxidil Extra Strength (For Men) with the FDA, including FlexiGo Inc, Roman Health Ventures Inc.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 09/20/2026 · Label text is shown as published by the manufacturer. Not medical advice