Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength

Manufacturer: ESALON.COM, LLC
Effective date: 2024-11-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:34:13

Label at a glance#

ProductColorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength

Active ingredientMINOXIDIL

Label structure8 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

Contacts and useful links#

PhoneLabel contact(866) 550-2424

Label contents#

Full prescribing information#

Active ingredient

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 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/PHARMACIST SECTION

heart disease.

When using this product

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 least 2 months with twice a day usage. For some men, you may need to use this product for at least 4 monhs 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

May be harmful is 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 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

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 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 20° to 25°C (68° to 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

Call your health professional or Colorsmith at toll free (866) 550-2424.
Visit website at Colorsmith.co

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelInner LabelInsert Label1Insert Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311724	minoxidil 5 % Topical Solution	PSN	1
311724	minoxidil 50 MG/ML Topical Solution	SCD	1
311724	minoxidil 3 GM per 60 ML Topical Solution	SY	1
311724	minoxidil 5 % Topical Solution	SY	1
311724	minoxidil 5 GM per 100 ML Topical Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MINOXIDIL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84856-603-00	Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60		1
84856-603-00	Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength	1 in 1 BOX	SOLUTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84856-603	COLORSMITH HAIR REGROWTH TREATMENT MENS MINOXIDIL TOPICAL SOLUTION EXTRA STRENGTH (MINOXIDIL) SOLUTION [ESALON.COM, LLC]	1	Current NDC, 2 package rows	20241106_69b01eab-df9f-4ae8-87e4-add18883874b.zip

Products#

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

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

Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength
MINOXIDIL
ALCOHOL
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84856-603	84856-603-00

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
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
MINOXIDIL	5965120SH1	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076239-001	THEROXIDIL	MINOXIDIL	5%	SOLUTION / TOPICAL			2004-08-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3a93d1ddd44b…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength	MINOXIDIL	ESALON.COM, LLC	69b01eab-df9f-4ae8-87e4-add18883874b	2024-11-05	Warnings	Exact identifier ndc (package): 84856-603-00 ndc (product): 84856-603 ndc11 (package): 84856060300 spl id: 262a7fae-86ee-a9c7-e063-6394a90a1fe8 spl set id: 69b01eab-df9f-4ae8-87e4-add18883874b

Reported adverse events (FAERS/openFDA)#

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