Peak Body Mens Hair Regrowth Treatment

Product NDC: 83121-001
Requested package NDC: 83121-001-01
11-digit product format: 831210001
Labeler code: 83121
Product ID: 83121-001_eea139e1-95b7-dd04-e053-2995a90a1965
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil 5%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Securemedical, Inc.
Application: ANDA076239
Marketing category: ANDA
Marketing start: 2022-11-29
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 5 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	83121-001	83121-001-01	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
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83121-001-01	2024-01-30	C162847	48780-1	1030e365-5ce0-111a-e063-dadaa90a10e2	Peak Body Minoxidil 5% Hair Regrowth treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83121-001-01	Peak Body Mens Hair Regrowth Treatment	3 in 1 BOX	SOLUTION	3		1
83121-001-01	Peak Body Mens Hair Regrowth Treatment	60 mL in 1 BOTTLE	SOLUTION	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83121-001	PEAK BODY MENS HAIR REGROWTH TREATMENT (MINOXIDIL 5%) SOLUTION [SECUREMEDICAL, INC.]	1	Legacy NDC, 2 package rows	20221130_eea139e1-95b6-dd04-e053-2995a90a1965.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INTELLIGENT Mens Minoxidil Extra Strength 5 Minoxidil	MINOXIDIL	INTELLIGENT ELEPHANT, LLC	b9156b21-b410-45ae-a9f0-517e427f5e9b	2026-08-03	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
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
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

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	eea139e1-95b6-dd04-e053-2995a90a1965	1
311724	minoxidil 50 MG/ML Topical Solution	SCD	eea139e1-95b6-dd04-e053-2995a90a1965	1
311724	minoxidil 3 GM per 60 ML Topical Solution	SY	eea139e1-95b6-dd04-e053-2995a90a1965	1
311724	minoxidil 5 % Topical Solution	SY	eea139e1-95b6-dd04-e053-2995a90a1965	1
311724	minoxidil 5 GM per 100 ML Topical Solution	SY	eea139e1-95b6-dd04-e053-2995a90a1965	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83121-001-01	83121000101	3 BOTTLE in 1 BOX (83121-001-01) > 60 mL in 1 BOTTLE	3 bottle	2022-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Peak Body Minoxidil 5% Hair Regrowth treatment	Securemedical, Inc. \| Pure Source, LLC	2022-11-29	HUMAN OTC DRUG LABEL	1