Dosage and administration
Apply one mL 2 times daily directly onto the scalp in the hair loss area. Using more or more often will not improve results. Continued use is necessary or hair loss will resume.
Apply one mL 2 times daily directly onto the scalp in the hair loss area. Using more or more often will not improve results. Continued use is necessary or hair loss will resume.
Minoxidil 5% w/v
Hair Regrowth Treatment For Men
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).
For external use only. Flammable: Keep away from fire or flame.
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 or 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.
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. Results may occur at 2 months with twice daily 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 everyone.
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.
If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)
Apply one mL 2 times daily directly onto the scalp in the hair loss area.
Using more or more often will not improve results.
Continued use is necessary or hair loss will resume.
See hair loss picture on the side of this carton.
Before use, read all information on carton and printed insert.
Keep the carton. It contains important information.
Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%.
In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.
Alcohol, Propylene Glycol, Purified water
1-800-237-7157
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 25280-006-42 | 2025-12-03 | C162847 | 48780-1 | 2cef2736-94a6-d83d-e063-dadaa90ab31f | d158d3af-6850-48c0-8355-9df0637684cc |
| 25280-006-42 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-94a6-d83d-e063-dadaa90ab31f | d158d3af-6850-48c0-8355-9df0637684cc |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25280-006-42 | Loesch Hair Regrowth FormulaUnscented Topical Solution Extra-Strength for Men | 1 in 1 PACKAGE | SOLUTION | 1 | 4 | |
| 25280-006-42 | Loesch Hair Regrowth FormulaUnscented Topical Solution Extra-Strength for Men | 60 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 60 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MINOXIDIL | ACTIVE INGREDIENT | 5965120SH1 | 2 | |
| MINOXIDIL | ACTIVE MOIETY | 5965120SH1 | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 25280-006 | 25280-006-42 |
| 63981-798 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINOXIDIL | 5965120SH1 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2001-06-13 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men | MINOXIDIL | Loesch Laboratory Consultant, INC. | d158d3af-6850-48c0-8355-9df0637684cc | 2025-12-03 | Warnings | 25280-006-42 25280-006 25280000642 450fe25c-0ed3-eb99-e063-6394a90a6f32 d158d3af-6850-48c0-8355-9df0637684cc |
| kirkland signature minoxidil | MINOXIDIL | Costco Wholesale Company | 010ca7df-1e79-44ea-9171-b9d239f141e1 | 2024-07-18 | Warnings | 63981-798 |
Adverse event summaries are temporarily unavailable. Other product information remains available.