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MINOXIDIL EXTRA STRENGTH (FOR MEN)

Minoxidil · Liquid

Over-the-counter ANDA

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Generic name

Minoxidil

Dosage form

Liquid

Route

Topical

Marketing category

ANDA · ANDA

Labeler

FlexiGo Inc

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Minoxidil	5 g/100mL	645146	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Liquid

Route of administration

Topical

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Arteriolar Vasodilation [PE]	PE	All 29 members
Arteriolar Vasodilator [EPC]	EPC	All 29 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

075598

Application type

ANDA · Abbreviated New Drug Application

Approval date

June 13, 2001

Sponsor

PERRIGO

Products on application

Submissions recorded

Products approved under application 075598.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	SOLUTION		MINOXIDIL	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 075598.
Type	No.	Action	Status	Date	Review
Supplement	18	Labeling	Approved	July 21, 2008	—
Supplement	9	Labeling	Approved	August 30, 2005	—
Supplement	13	Labeling	Approved	July 14, 2005	—
Supplement	4	Labeling	Approved	August 9, 2004	—
Original application	1		Approved	June 13, 2001	—

Review documents

0 · Original application · July 22, 2015
0 · Original application · June 9, 2004
0 · Original application · June 13, 2001

Adverse event reports

Source: openFDA FAERS

44,695

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MINOXIDIL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
85524-2614-2	85524-2614	FlexiGo Inc	1 BOTTLE in 1 BOX (85524-2614-2) / 60 mL in 1 BOTTLE (85524-2614-1)	September 22, 2026
85524-2615-2	85524-2615	FlexiGo Inc	1 BOTTLE in 1 BOX (85524-2615-2) / 60 mL in 1 BOTTLE (85524-2615-1)	September 22, 2026
85524-2614	85524-2614	FlexiGo Inc	—	September 22, 2026
85524-2615	85524-2615	FlexiGo Inc	—	September 22, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.