• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist • apply one mL with spray (6 sprays) 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
www.thickhead.comMinoxidil 5% w/v
Hair regrowth treatment
to regrow hair on the scalp (vertex only, see picture on side of carton)
For external use only. For use by men 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. 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, irritated or painful • you use other medicines on the scalp
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.
• 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
If swallowed, get medical help or contact a Poison Control Center right away.
• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist • apply one mL with spray (6 sprays) 2 times a daydirectly 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
• see hair loss pictures on side of this carton • before use, read all information on carton and enclosed leaflet • 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 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-45 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution • store at controlled room temperature 20º to 25ºC (68º to 77ºF).
Alcohol, Propylene Glycol, Purified Water
1-(800)-555-5163
Visit Website at www.thickhead.com
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70550-602-01 | 2023-11-15 | C162847 | 48780-1 | f386c649-c779-0266-e053-dadaa90a7c1a | THICK HEAD Extra Strength for Men 5% Minoxidil Topical Solution |
| 70550-602-03 | 2023-11-15 | C162847 | 48780-1 | f386c649-c779-0266-e053-dadaa90a7c1a | THICK HEAD Extra Strength for Men 5% Minoxidil Topical Solution |
| 70550-602-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-c779-0266-e053-dadaa90a7c1a | THICK HEAD Extra Strength for Men 5% Minoxidil Topical Solution |
| 70550-602-03 | 2023-01-30 | C162847 | 48780-1 | f386c649-c779-0266-e053-dadaa90a7c1a | THICK HEAD Extra Strength for Men 5% Minoxidil Topical Solution |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70550-602 | 70550-602-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A076239-001 | THEROXIDIL | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 |
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 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076239-001 | THEROXIDIL | 5% | SOLUTION / TOPICAL | 2004-08-24 | 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 |
|---|---|---|---|---|---|---|
| 4723f19c-7e23-dfbb-e063-6294a90a526c | 8d58d0d3-0427-d045-e053-2995a90ac8e7 | 2025-12-29 | Warnings | 8d58d0d3-0427-d045-e053-2995a90ac8e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.