hims

Manufacturer
Clubroom, Inc.
Effective date
2017-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:53:53

Label at a glance#

Producthims
Active ingredientMINOXIDIL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

OTC - PURPOSE SECTION

Hair regrowth treatment for men

INDICATIONS & USAGE SECTION

to regrow hair on the scalp (vertex only, see picture on side of carton)

WARNINGS SECTION

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.

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.

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

• 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 18-49 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).

INACTIVE INGREDIENT SECTION

alcohol, propylene glycol, purified water

OTC - QUESTIONS SECTION

Questions or Comments: Call toll-free 1 (800) 368-0038 or Visit Website at www.forhims.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN4
311724minoxidil 50 MG/ML Topical SolutionSCD4
311724minoxidil 3 GM per 60 ML Topical SolutionSY4
311724minoxidil 5 % Topical SolutionSY4
311724minoxidil 5 GM per 100 ML Topical SolutionSY4

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
71730-042-082020-01-31C16284748780-19d75b9cf-ebc7-f424-e053-dadaa90a57ce5d8460fc-cd6f-72af-e053-2a91aa0ad2f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71730-042-08hims60 mL in 1 BOTTLELIQUID604
71730-042-08hims1 in 1 BOXLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71730-042HIMS (MINOXIDIL 5%) LIQUID [CLUBROOM, INC.]4Legacy NDC, 2 package rows20171231_5d8460fc-cd6f-72af-e053-2a91aa0ad2f3.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71730-04271730-042-08

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
A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2000-11-17

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 22:38:342026-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075518-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2000-11-17f41ea6bd6efb…

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
619619ab-05ce-c750-e053-2a91aa0aa1525d8460fc-cd6f-72af-e053-2a91aa0ad2f32017-12-30WarningsExact identifier
spl id: 619619ab-05ce-c750-e053-2a91aa0aa152
spl set id: 5d8460fc-cd6f-72af-e053-2a91aa0ad2f3

Reported adverse events (FAERS/openFDA)#

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