Daniel Alain Hair Regrowth Treatment for Women

Product NDC: 82545-001
Requested package NDC: 82545-001-01
11-digit product format: 825450001
Labeler code: 82545
Product ID: 82545-001_d738e981-fc77-3740-e053-2995a90a686e
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil 2%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Daniel Alain, Inc
Application: ANDA078176
Marketing category: ANDA
Marketing start: 2022-02-04
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 2 g/100mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82545-001	82545-001-01	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078176-001	THEROXIDIL	MINOXIDIL	2%	SOLUTION / TOPICAL			2007-11-09

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82545-001-01	2024-01-30	C162847	48780-1	1030e365-6aae-111a-e063-dadaa90a10e2	Daniel Alain - Women's 2% Minoxidil Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82545-001-01	Daniel Alain Hair Regrowth Treatment for Women	1 in 1 BOX	SOLUTION	1		2
82545-001-01	Daniel Alain Hair Regrowth Treatment for Women	60 mL in 1 BOTTLE	SOLUTION	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82545-001	DANIEL ALAIN HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL 2%) SOLUTION [DANIEL ALAIN, INC]	2	Legacy NDC, 2 package rows	20220205_d73826a6-ce52-2d08-e053-2a95a90ab0ae.zip

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment	MINOXIDIL	WR Group, Inc.	a765cc59-ab59-4e49-ba28-926a2e0a78b1	2026-05-13	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
MDhair hair regrowth treatment for women	MINOXIDIL 2%	MDalgorithms, Inc	c3ba93d7-e826-f6ac-e053-2a95a90a7951	2026-04-24	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Minoxidil Topical Solution USP, 2%	MINOXIDIL 2%	Carol's Daughter, LLC	4d659f8f-b721-cf3b-e063-6394a90a50f6	2026-03-19	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Fete Health Hair Regrowth Treatment for Women	MINOXIDIL	Honest Pharma LLC	93f7a89b-65f1-4a58-af75-2eeb0e47a8f8	2026-02-11	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Womens MinoGrow Hair Regrowth Treatment Minoxidil	MINOXIDIL	Minogro Products, LLC	890c2acf-0c08-4c45-b29f-928b6155ca00	2026-02-03	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Happy Head Womens Hair Regrowth Treatment	MINOXIDIL	Happy Head, Inc	1e447c66-a8c9-42a4-94e9-b8739543834e	2025-09-24	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Gemachlich ZuHause Hair Growth Foam (Women)	HAIR GROWTH FOAM (WOMEN)	Guangdong Quadrant Ecological Technology Co., Ltd.	3af47ccf-dde0-4f8a-e063-6294a90a28d8	2025-07-27	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN	MINOXIDIL 2%	Rida LLC	0d027e41-8acb-43c0-b9e4-4d3208dc7b37	2025-02-25	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented	MINOXIDIL	SANTO REMEDIO LLC	2a2d814f-d716-6e60-e063-6294a90aeb97	2024-12-26	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented	MINOXIDIL	SANTO REMEDIO LLC	cfc7adf1-627b-41e1-b51a-cdcd8a14e796	2024-12-18	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System	MINOXIDIL	Invest Strong, LLC	2e19bf51-1769-4bc1-9232-9aa4b8df5847	2024-12-05	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
eSalon Hair Regrowth Treatment Womens Minoxidil	MINOXIDIL	ESALON.COM, LLC	c3951cc3-83c1-4d9d-8fbe-db6f1fb3986c	2024-11-05	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
KERANIQUE Hair Regrowth Treatment For Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	8d580c01-a13d-81f8-e053-2a95a90a7426	2024-08-22	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Keranique 2% Hair Regrowth Treatment for Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	c781447a-10f1-70e3-e053-2995a90a40f8	2024-08-22	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
GROWELL Womens Hair Regrowth Treatment 2 Minoxidil	MINOXIDIL	APIRA SCIENCE, INC.	8b81a5e5-315e-4b7d-8ffd-623382294d8a	2024-05-16	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
BOSLEY Minoxidil Topical Solution 2 for Women	MINOXIDIL	Scientific Hair Research, LLC	4fe1602f-797a-4469-b82c-3ade8a9c7fec	2024-02-21	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
BOSLEY Woman 2 Minoxidil Topical Solution	MINOXIDIL	Scientific Hair Research, LLC	a70d0bd4-ac02-4a55-b9e7-c20dfe830f08	2023-12-18	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Womens Minoxidil Hair Growth System	MINOXIDIL	Topiderm, Inc.	6cd3532a-1c1d-44bb-9f7e-c9dc085e2f96	2021-04-23	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5965120SH1	MINOXIDIL	38304-91-5	MINOXIDIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311723	minoxidil 2 % Topical Solution	PSN	d73826a6-ce52-2d08-e053-2a95a90ab0ae	2
311723	minoxidil 20 MG/ML Topical Solution	SCD	d73826a6-ce52-2d08-e053-2a95a90ab0ae	2
311723	minoxidil 2 % Topical Solution	SY	d73826a6-ce52-2d08-e053-2a95a90ab0ae	2
311723	minoxidil 2 GM per 100 ML Topical Solution	SY	d73826a6-ce52-2d08-e053-2a95a90ab0ae	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82545-001-01	82545000101	1 BOTTLE in 1 BOX (82545-001-01) > 60 mL in 1 BOTTLE	1 bottle	2022-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Daniel Alain - Women's 2% Minoxidil Topical Solution	Daniel Alain, Inc	2022-02-04	HUMAN OTC DRUG LABEL	2