minoxidil solution

Manufacturer
Nutrastim Hair LLC
Effective date
2019-11-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:23

Label at a glance#

Productminoxidil solution
Active ingredientMINOXIDIL
Label structure14 sections

Dosage and administration

Apply 1 ml, 2 times daily directly with the dropper 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.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

To regrow hair on the scalp.

WARNINGS SECTION

  • For external use only.
  • For use by women only.
  • Flammable. Keep away from fire or flame.

OTC - DO NOT USE SECTION

  • Your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you.
  • You have no family history of hair loss.
  • Your hair loss is sudden and/or patchy.
  • Your hair loss is associated with child birth.
  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease

OTC - WHEN USING SECTION

  • 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 women, you may need to use this product for at least 4 months before you see results.
  • The amount of hair regrowth is different with each person. This product will not work for all women.

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

May be harmful if used when pregnant or breast-feeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply 1 ml, 2 times daily directly with the dropper 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.

Other information

INDICATIONS & USAGE SECTION

  • Before use see hair loss pictures on side of this box.
  • Keep the box, it contains important information.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution was 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • Store at 20° to 25° C (68° to 77° F).

Keep tightly closed.

INACTIVE INGREDIENT SECTION

Alcohol, propylene glycol, purified water

OTC - QUESTIONS SECTION

Call us at 1-844-892-8578

Visit nutrastimhair.com

for more information about hair thinning, visit

nutrastimhair.com/women-education/

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 2% w/v

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Minoxidil LabelMinoxidil Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311723minoxidil 2 % Topical SolutionPSN3
311723minoxidil 20 MG/ML Topical SolutionSCD3
311723minoxidil 2 % Topical SolutionSY3
311723minoxidil 2 GM per 100 ML Topical SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71517-001-022023-01-30C16284748780-1f386c64a-1b56-0266-e053-dadaa90a7c1aNUTRASTIM HAIR REGROWTH TREATMENT FOR WOMEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71517-001-01minoxidil solution60 mL in 1 BOTTLE, DROPPERSOLUTION603
71517-001-02minoxidil solution2 in 1 CARTONSOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71517-001MINOXIDIL SOLUTION SOLUTION [NUTRASTIM HAIR LLC]3Legacy NDC, 2 package rows20191103_53f66d84-c5b2-1a90-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71517-00171517-001-01, 71517-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2001-06-13

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1384e616aacf4f…
2026-08-18 06:07:402026-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133f01610625f2…
2019-09-15 20:21 UTC2019-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96613a74-42a5-0d23-e053-2995a90a577d53f66d84-c5b2-1a90-e054-00144ff88e882019-11-02WarningsExact identifier
spl id: 96613a74-42a5-0d23-e053-2995a90a577d
spl set id: 53f66d84-c5b2-1a90-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.