OpusMeds Extra Strength Minoxidil

Product NDC: 87338-983
11-digit product format: 873380983
Labeler code: 87338
Product ID: 87338-983_494a6bca-19c5-f856-e063-6294a90ab251
Type: HUMAN OTC DRUG
Nonproprietary name: MINOXIDIL
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Opus Meds LLC
Application: ANDA076239
Marketing category: ANDA
Marketing start: 2026-01-06
Substance: MINOXIDIL
Active strength: 50 mg/mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2022-10-28 04:53 UTC	2022-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: OpusMeds Extra Strength Minoxidil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOXIDIL	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5965120SH1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311724	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eab00b6d-d49a-4090-8243-ae5e99f6a54e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
87338-983-00	OpusMeds Extra Strength Minoxidil	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60		1
87338-983-00	OpusMeds Extra Strength Minoxidil	1 in 1 BOX	SOLUTION	1		1

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Follicly Minoxidil Hair Regrowth Treatment	MINOXIDIL	Follicly LLC	7cc287ea-d5d3-4bd6-b118-e103992126f9	2026-07-30	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Nuvarra Mens Minoxidil Hair Regrowth Treatment	MINOXIDIL	Bionetics Health LLC	6b11b347-6a07-4998-b127-1edfad4965d7	2026-06-17	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Mens Jivexa Extra Strength Minoxidil	MINOXIDIL	SMC Essentials LLC	7f77f4de-e66a-4352-a6d3-809c78824953	2026-05-14	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment	MINOXIDIL	WR Group, Inc.	9eac6012-4db8-455e-a60c-bb06c70884cf	2026-05-13	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil	MINOXIDIL	TrueRoot Labs LLC	de865d37-d99f-4f9d-8c09-472a308e2e91	2026-05-06	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Mens Extra Strength Minoxidil Hair Growth Treatment	MINOXIDIL	Hairmax International, LLC	7ee426fe-7a13-4327-b333-9651d6871a73	2026-04-30	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
MDhair Extra Strength hair regrowth treatment for Men	MINOXIDIL 5%	MDalgorithms, Inc	c3b9690c-723d-cc8f-e053-2a95a90ae906	2026-04-24	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
OpusMeds Extra Strength Minoxidil	MINOXIDIL	Opus Meds LLC	eab00b6d-d49a-4090-8243-ae5e99f6a54e	2026-01-26	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239 ndc (product): 87338-983
Dr. Bosley Minoxidil (For Men) Hair Regrowth Treatment	MINOXIDIL	Scientific Hair Research, LLC	94da001e-4f5d-43c3-b5e9-48401203513c	2025-12-09	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
RegrowthX Hair Regrowth Treatment Minoxidil	MINOXIDIL	Nimex Group Inc	77f70f47-8122-481c-b5f1-17e467f2c81b	2025-10-06	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Happy Head Mens Extra Strength Minoxidil	MINOXIDIL	Happy Head, Inc	d3b4bc29-38c9-4180-a6d1-1ab1891897a2	2025-10-06	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength	MINOXIDIL	NUEPHASE LLC	fb838abf-43bf-4f7d-af78-18b7145946f4	2025-09-15	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment	MINOXIDIL	DS Healthcare Group	f11e1944-dea6-469f-9ef4-ccce47a7e0fe	2025-05-01	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
ProBliva Mens Extra Strength Minoxidil	MINOXIDIL	CAVTECH HOLDING LLC	84a2f311-e74c-4b50-bc55-dac604ca7694	2025-04-21	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Remixdil Extra Strength hair regrowth treatment for Men	MINOXIDIL 5%	Rida LLC	8a34f20e-e959-4b53-b06c-b13eb9953649	2025-02-25	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Minoxidil Extra Strength for Men	MINOXIDIL	Roman Health Ventures Inc.	03738dd6-a42c-0986-e063-6294a90a1cc0	2025-01-30	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Stafenit Hair Regrowth Treatment Topical Minoxidil	MINOXIDIL	Cozesmo	cd74cc10-6df4-47bf-885e-333244db6d82	2025-01-09	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Minoxidil Extra Strength for Men	MINOXIDIL	Roman Health Ventures Inc.	a568aba1-1016-4380-e053-2a95a90a396d	2025-01-08	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Tomum Hair Growth Treatment For Men Minoxidil Unscented	MINOXIDIL	BELLEKA INC	4c0582a3-f2be-4e53-a174-12269f7ddad0	2024-12-04	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
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 application applno (ANDA): 076239 application number: ANDA076239

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
311724	minoxidil 5 % Topical Solution	PSN	eab00b6d-d49a-4090-8243-ae5e99f6a54e	1
311724	minoxidil 50 MG/ML Topical Solution	SCD	eab00b6d-d49a-4090-8243-ae5e99f6a54e	1
311724	minoxidil 3 GM per 60 ML Topical Solution	SY	eab00b6d-d49a-4090-8243-ae5e99f6a54e	1
311724	minoxidil 5 % Topical Solution	SY	eab00b6d-d49a-4090-8243-ae5e99f6a54e	1
311724	minoxidil 5 GM per 100 ML Topical Solution	SY	eab00b6d-d49a-4090-8243-ae5e99f6a54e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87338-983-00	87338098300	1 BOTTLE, DROPPER in 1 BOX (87338-983-00) / 60 mL in 1 BOTTLE, DROPPER	2026-01-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OpusMeds Extra Strength 5% Minoxidil Topical Solution USP	Opus Meds LLC \| Pure Source, LLC	2026-01-26	HUMAN OTC DRUG LABEL	1