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GOOD SENSE HAIR REGROWTH TREATMENT
Minoxidil · Solution
Overview
Active ingredients
Source: NDC DirectoryForms, 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 |
|---|---|---|---|---|---|---|---|
| 075357-001 | MINOXIDIL (FOR MEN) | SOLUTION | MINOXIDIL | Over-the-counter | — | ||
| 075357-002 | MINOXIDIL (FOR WOMEN) | SOLUTION | MINOXIDIL | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 24 | Labeling | Approved | March 30, 2016 | Standard |
| Supplement | 14 | Labeling | Approved | October 8, 2008 | — |
| Supplement | 5 | Labeling | Approved | July 14, 2005 | — |
| Original application | 1 | Approved | July 30, 1999 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260806). 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 carton)
Purpose
openFDA Drug LabelingPurpose Hair regrowth treatment for men
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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
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 2% w/v
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 |
|---|---|---|---|---|
| 0113-1032-30 | 0113-1032 | L. Perrigo Company | 3 BOTTLE, DROPPER in 1 CARTON (0113-1032-30) / 60 mL in 1 BOTTLE, DROPPER (0113-1032-16) | May 25, 2021 |
| 0113-1032-40 | 0113-1032 | L. Perrigo Company | 6 BOTTLE, DROPPER in 1 CARTON (0113-1032-40) / 60 mL in 1 BOTTLE, DROPPER (0113-1032-16) | July 29, 2021 |
| 0113-6500-30 | 0113-6500 | L. Perrigo Company | 3 BOTTLE in 1 CARTON (0113-6500-30) / 60 mL in 1 BOTTLE (0113-6500-00) | October 24, 2025 |
| 0113-1032 | 0113-1032 | L. Perrigo Company | — | May 25, 2021 |
| 0113-6500 | 0113-6500 | L. Perrigo Company | — | October 24, 2025 |
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 · 11 sections on this page.