MINOXIDIL 5% (FOR WOMEN)
- Product NDC
- 58602-104
- 11-digit product format
- 586020104
- Labeler code
- 58602
- Product ID
- 58602-104_72ef2c23-c4fe-4595-9c44-d69396ed2c37
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MINOXIDIL
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Aurohealth LLC
- Application
- ANDA218616
- Marketing category
- ANDA
- Marketing start
- 2026-06-19
- Substance
- MINOXIDIL
- Active strength
- 50 mg/g
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218616-001 | MINOXIDIL (FOR MEN) | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | ||
| A218616-002 | MINOXIDIL (FOR WOMEN) | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 |
Observed Orange Book product history#
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 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | 8072bd15b7f6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218616-001 | MINOXIDIL (FOR MEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218616-002 | MINOXIDIL (FOR WOMEN) | 5% | AEROSOL, FOAM / TOPICAL | 2024-04-22 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MINOXIDIL 5% (FOR WOMEN)
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINOXIDIL | 50 mg/g |
openFDA label cross-check#
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58602-104-23 | 58602010423 | 3 CAN in 1 CARTON (58602-104-23) / 60 g in 1 CAN | 3 can | 2026-06-19 | No | No | Current |