Loesch Hair Regrowth Formula

Manufacturer
Loesch Laboratory Consultant, INC. | Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:06

Label at a glance#

ProductLoesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men
Active ingredientMINOXIDIL
Label structure15 sections

Dosage and administration

Apply one mL 2 times daily directly onto the scalp in the hair loss area. Using more or more often will not improve results. Continued use is necessary or hair loss will resume.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

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 pictures on side of carton).

Warnings

WARNINGS SECTION

For external use only. Flammable: Keep away from fire or flame.

Do not use if

WARNINGS 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. 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 or children.
Your scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the scalp.

ASK DOCTOR

WARNINGS SECTION

Ask a doctor before use if you have heart disease.

When using this product

WARNINGS 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. Results may occur at 2 months with twice daily 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 everyone.

Stop use and ask a doctor if you have

WARNINGS 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.

Pregnancy or breast feeding

WARNINGS SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Apply one mL 2 times daily directly onto the scalp in the hair loss area.
Using more or more often will not improve results.
Continued use is necessary or hair loss will resume.

Other information

OTHER SAFETY INFORMATION

See hair loss picture on the side of this carton.
Before use, read all information on carton and printed insert.
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 Minoxidil Topical Solution 5%.
In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified water

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-237-7157

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

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
25280-006-422025-12-03C16284748780-12cef2736-94a6-d83d-e063-dadaa90ab31fd158d3af-6850-48c0-8355-9df0637684cc
25280-006-422025-01-30C16284748780-12cef2736-94a6-d83d-e063-dadaa90ab31fd158d3af-6850-48c0-8355-9df0637684cc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25280-006-42Loesch Hair Regrowth FormulaUnscented Topical Solution Extra-Strength for Men1 in 1 PACKAGESOLUTION14
25280-006-42Loesch Hair Regrowth FormulaUnscented Topical Solution Extra-Strength for Men60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINOXIDILACTIVE INGREDIENT5965120SH12
MINOXIDILACTIVE MOIETY5965120SH12
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
WATERINACTIVE INGREDIENT059QF0KO0R2

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
25280-00625280-006-42
63981-798

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for MenMINOXIDILLoesch Laboratory Consultant, INC.d158d3af-6850-48c0-8355-9df0637684cc2025-12-03WarningsExact identifier
ndc (package): 25280-006-42
ndc (product): 25280-006
ndc11 (package): 25280000642
spl id: 450fe25c-0ed3-eb99-e063-6394a90a6f32
spl set id: d158d3af-6850-48c0-8355-9df0637684cc
kirkland signature minoxidilMINOXIDILCostco Wholesale Company010ca7df-1e79-44ea-9171-b9d239f141e12024-07-18WarningsExact identifier
ndc (product): 63981-798

Reported adverse events (FAERS/openFDA)#

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