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MINOXIDIL 5% (FOR MEN)
Minoxidil · Aerosol, Foam
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Minoxidil | 50 mg/g | 645146 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Arteriolar Vasodilation [PE] | PE | All 29 members |
| Arteriolar Vasodilator [EPC] | EPC | All 29 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 218616-001 | MINOXIDIL (FOR MEN) | AEROSOL, FOAM | MINOXIDIL | Over-the-counter | — | ||
| 218616-002 | MINOXIDIL (FOR WOMEN) | AEROSOL, FOAM | MINOXIDIL | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | April 22, 2024 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260122). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Purpose
openFDA Drug LabelingPurpose Hair regrowth treatment for men
Dosage and Administration
openFDA Drug LabelingDirections apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use 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
openFDA Drug LabelingWarnings For external use only. For use by men only. Extremely Flammable : Avoid fire, flame, or smoking during and immediately following application.
Do Not Use
openFDA Drug LabelingDo not use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam 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
openFDA Drug LabelingAsk a doctor before use if you have heart disease
Stop Use
openFDA Drug LabelingStop 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
Active Ingredient
openFDA Drug LabelingActive ingredient Minoxidil USP 5% w/w (without propellant)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: MINOXIDIL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 58602-608-01 | 58602-608 | Aurohealth LLC | 1 CAN in 1 CARTON (58602-608-01) / 60 g in 1 CAN | April 22, 2024 |
| 58602-608-02 | 58602-608 | Aurohealth LLC | 2 CAN in 1 CARTON (58602-608-02) / 60 g in 1 CAN | April 22, 2024 |
| 58602-608-03 | 58602-608 | Aurohealth LLC | 3 CAN in 1 CARTON (58602-608-03) / 60 g in 1 CAN | April 22, 2024 |
| 58602-608-04 | 58602-608 | Aurohealth LLC | 4 CAN in 1 CARTON (58602-608-04) / 60 g in 1 CAN | April 22, 2024 |
| 58602-608-05 | 58602-608 | Aurohealth LLC | 6 CAN in 1 CARTON (58602-608-05) / 60 g in 1 CAN | April 22, 2024 |
| 21130-208-03 | 21130-208 | Better Living Brands, LLC | 3 CAN in 1 CARTON (21130-208-03) / 60 g in 1 CAN | July 3, 2026 |
| 58602-608 | 58602-608 | Aurohealth LLC | — | April 22, 2024 |
| 21130-208 | 21130-208 | Better Living Brands, LLC | — | July 3, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.