Hair lossActive ingredient
Minoxidil
Topical hair regrowth treatment2 FDA labels read
Topical minoxidil is the only hair loss treatment in this category available without a prescription. It is sold under a Drug Facts label, in separate products for men and for women. Both are 5 percent minoxidil, but they differ in presentation and in how often the label says to apply them.
Highlights of the labels
- Men's Rogaine Extra Strength
- Hair regrowth on the scalp, mencovers hair loss
- Women's Rogaine
- Hair regrowth on the scalp, womencovers hair loss
- Supply
- Over the counter
- Generic
- 19 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| Men's Rogaine Extra StrengthKenvue Brands LLC | What its label approvesHair regrowth on the scalp, menCovers hair loss | SupplyOver the counter | Label version6 September 2024 |
| Women's RogaineKenvue Brands LLC | What its label approvesHair regrowth on the scalp, womenCovers hair loss | SupplyOver the counter | Label version13 November 2024 |
How it works
Minoxidil was first developed as an oral medication for high blood pressure, and hair growth was observed as a side effect. The over-the-counter Drug Facts label does not describe a mechanism; it states the purpose of the product, which is hair regrowth treatment.
What this product is for
The approved uses, as worded in the label.
Men's Rogaine Extra Strength
- Hair regrowth treatment for men
- to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Women's Rogaine
- Hair regrowth treatment for women
- to regrow hair on the top of the scalp (see pictures on side of this carton)
Active ingredient
The presentations and strengths listed in the label.
Men's Rogaine Extra Strength
Minoxidil 5% w/v
Women's Rogaine
Minoxidil 5% w/w (without propellant)
Directions
What the label states about administration. It is not a dosing instruction for any individual.
Men's Rogaine Extra Strength
- 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
Women's Rogaine
- see enclosed booklet for complete directions on how to use
- apply half a capful once daily directly to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- 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
Stop use and ask a doctor if
The adverse reactions the label reports as most common.
Men's Rogaine Extra Strength
- 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
Women's Rogaine
- 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 6 months
Warnings
The warnings and precautions section of the label.
Men's Rogaine Extra Strength
- Ask a doctor before use if you have heart disease
- 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.
Women's Rogaine
- Ask a doctor before use if you have heart disease
- do not use more than directed
- 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 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
- the amount of hair regrowth is different for each person. This product will not work for all women.
Do not use if
Situations in which the label states the medication must not be used.
Men's Rogaine Extra Strength
- 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, irritated, or painful
- you use other medicines on the scalp
Women's Rogaine
- your degree of hair loss is different than that shown on side of this carton because this product may not work for you
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- your hair loss is associated with childbirth
- 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
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Men's Rogaine Extra Strength
May be harmful if used when pregnant or breast-feeding.
Women's Rogaine
May be harmful if used when pregnant or breast-feeding.
Generic or brand
Generic topical minoxidil is approved and sold widely, including under retailer own brands. The active ingredient and its concentration are printed on every Drug Facts label.
The FDA label database lists 19 approved generic applications for this ingredient.
What affects the cost
Because it is sold over the counter and has many approved generics, minoxidil is the least expensive option in this category. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programmes. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Generic |
|---|---|
| per gram | Generic$0.278 (range $0.251 to $0.313, 40 listings) |
| per millilitre | Generic$0.281 (range $0.281 to $0.281, 6 listings) |
Median of 46 listings. Effective dates 2025-02-19 to 2026-07-22, file dated 2026-07-29.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Do the men's and women's products differ?
- They are separate FDA approvals with separate Drug Facts labels. Both list minoxidil at 5 percent, but the presentations and the directions differ: the men's label covers a solution applied twice a day, and the women's label covers a foam applied once a day. The men's label also states that the product is not intended for frontal baldness or a receding hairline.
- What does the label say about how long it takes?
- The men's label states that results may occur at 2 months with twice a day use, and that some men may need to use the product for at least 4 months before results are seen. It also states that continued use is necessary or hair loss will begin again.
- Is oral minoxidil the same thing?
- No. Oral minoxidil is approved for high blood pressure, not for hair loss, and it carries a boxed warning. The pages here cover the topical products approved under a Drug Facts label for hair regrowth.
Other medications under hair loss
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Men's Rogaine Extra Strength
Kenvue Brands LLC. Label version 5, effective 6 September 2024.
FDA prescribing information for Women's Rogaine
Kenvue Brands LLC. Label version 6, effective 13 November 2024.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 18 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.