Minoxidil

Product NDC: 56062-798
11-digit product format: 560620798
Labeler code: 56062
Product ID: 56062-798_994c849a-a30c-473b-87fd-ce7fc9a0a535
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Publix Super Markets Inc
Application: ANDA075598
Marketing category: ANDA
Marketing start: 2010-10-25
Marketing end: 0000-00-00
Substance: MINOXIDIL
Active strength: 3 g/60mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	56062-798		D	Discontinued by firm		2026-10-05
excluded package	package	56062-798	56062-798-16	D	Discontinued by firm		2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	56062-798		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	56062-798	56062-798-16	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION / TOPICAL			2001-06-13

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
56062-798-16	ML - Milliliter	56062-798	d8c2bb4a-0d60-49a8-a24d-29a79c325748	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOXIDIL	ACTIVE INGREDIENT	5965120SH1	MINOXIDIL SOLUTION [PUBLIX SUPER MARKETS INC]	2
MINOXIDIL	ACTIVE MOIETY	5965120SH1	MINOXIDIL SOLUTION [PUBLIX SUPER MARKETS INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MINOXIDIL SOLUTION [PUBLIX SUPER MARKETS INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MINOXIDIL SOLUTION [PUBLIX SUPER MARKETS INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MINOXIDIL SOLUTION [PUBLIX SUPER MARKETS INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-798	MINOXIDIL SOLUTION [PUBLIX SUPER MARKETS INC]	4	Legacy NDC	20210806_0b822988-2d8c-4e16-aafd-6058008c0910.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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Minoxidil	MINOXIDIL	Cardinal Health 110, LLC. dba Leader	fbb17735-6c1f-44d6-865b-feec83a66b69	2024-03-04	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	98f780ad-dc07-4d37-a05d-fc7b45b0c474	2021-09-29	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56062-798-16	56062079816	1 BOTTLE in 1 CARTON (56062-798-16) > 60 mL in 1 BOTTLE	1 bottle	2010-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix Super Markets, Inc. Minoxidil Topical Solution USP 5% Drug Facts	Publix Super Markets Inc	2021-08-05	HUMAN OTC DRUG LABEL	4