FDA.reportPublic FDA data

DAW Minoxidil Topical Solution Mens Hair Regrowth Treatment 5

Manufacturer
Good Manager Holdings Inc
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:02

Label at a glance#

ProductDAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment
Active ingredientMINOXIDIL
Label structure8 sections

Dosage and administration

apply one mL with dropper 2 times a days 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#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%

Purpose

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 of carton)

Warnings

WARNINGS SECTION

For external use only. For use by men only.

Flammable:Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

  • 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, infected, irritated or painful
  • you use other medicines on the scalp

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - WHEN USING SECTION

  • do not apply on other part of the body
  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amount of cool tap water
  • some people have experienced changes in hair colour 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

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

May be harmful if used

when pregnant or breast-feeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children and pets.

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 days 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

SPL UNCLASSIFIED SECTION

  • 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 tratment 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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

Visit Website at davvhealth.com

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN2
311724minoxidil 50 MG/ML Topical SolutionSCD2
311724minoxidil 3 GM per 60 ML Topical SolutionSY2
311724minoxidil 5 % Topical SolutionSY2
311724minoxidil 5 GM per 100 ML Topical SolutionSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82372-482-00DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment1 in 1 BOXLIQUID12
82372-482-00DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82372-482DAVV MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT (MINOXIDIL) LIQUID [GOOD MANAGER HOLDINGS INC]2Current NDC, 2 package rows20241106_16b36a38-72c3-4a19-a28c-757ae02e097a.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
82372-48282372-482-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24c2088c7a36db…
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…

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
DAVV Minoxidil Topical Solution Mens Hair Regrowth TreatmentMINOXIDILGood Manager Holdings Inc16b36a38-72c3-4a19-a28c-757ae02e097a2024-10-28WarningsExact identifier
ndc (package): 82372-482-00
ndc (product): 82372-482
ndc11 (package): 82372048200
spl id: 258791e7-47ff-e41c-e063-6394a90a9aec
spl set id: 16b36a38-72c3-4a19-a28c-757ae02e097a

Reported adverse events (FAERS/openFDA)#

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