GROFULLY 5% Minoxidil Topical Solution

Manufacturer
TTEM, Inc
Effective date
2022-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:32

Label at a glance#

ProductGROFULLY Mens Extra Strength Hair Regrowth Treatment
Active ingredientMINOXIDIL
Label structure15 sections

Dosage and administration

• 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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

OTC - PURPOSE SECTION

Hair regrowth treatment for men

USE

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

Flammable: Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use if

  • 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% 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 or children.
  • Your scalp is red, inflammed, infected, irritated, or painful
  • You use other medicines on your scalp

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease

OTC - WHEN USING SECTION

When using this product

  • Do not apply on other parts of the body
  • Avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • Some people have experienced change 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.

OTC - STOP USE SECTION

Stop use and ask 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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 Information

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 68º to 77ºF (20º to 25ºC).

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

OTC - QUESTIONS SECTION

Questions or comments

Call toll-free 1-800-559-7691

or visit grofully.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN1
311724minoxidil 50 MG/ML Topical SolutionSCD1
311724minoxidil 3 GM per 60 ML Topical SolutionSY1
311724minoxidil 5 % Topical SolutionSY1
311724minoxidil 5 GM per 100 ML Topical SolutionSY1

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
70150-007-012024-01-30C16284748780-11030e365-0af2-111a-e063-dadaa90a10e2GROFULLY 5% Minoxidil Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70150-007-01GROFULLY Mens Extra Strength Hair Regrowth Treatment1 in 1 BOXSOLUTION11
70150-007-01GROFULLY Mens Extra Strength Hair Regrowth Treatment60 mL in 1 BOTTLESOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70150-007GROFULLY MENS EXTRA STRENGTH HAIR REGROWTH TREATMENT (MINOXIDIL 5%) SOLUTION [TTEM, INC]1Legacy NDC, 2 package rows20220125_d65f3429-c65d-e688-e053-2995a90ab4df.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
70150-00770150-007-01

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
A076239-001THEROXIDILMINOXIDIL5%SOLUTION / TOPICAL2004-08-24

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 22:38:342026-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f01610625f2…
2019-09-15 20:21 UTC2019-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24f41ea6bd6efb…

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
d65f3429-c65e-e688-e053-2995a90ab4dfd65f3429-c65d-e688-e053-2995a90ab4df2022-01-24WarningsExact identifier
spl id: d65f3429-c65e-e688-e053-2995a90ab4df
spl set id: d65f3429-c65d-e688-e053-2995a90ab4df

Reported adverse events (FAERS/openFDA)#

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