Regoxidine — Aerosol, Foam

Overview

Brand name

Regoxidine (For Men)

Generic name

Minoxidil

Dosage form

Aerosol, Foam

Route

Topical

Marketing category

ANDA · ANDA

Labeler

Innovus Pharmaceuticals, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Minoxidil	50 mg/g	645146	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Aerosol, Foam

Route of administration

Topical

Presentations

4

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

209074

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 31, 2018

Sponsor

TARO

Products on application

2

Submissions recorded

6

Products approved under application 209074.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
209074-001	MINOXIDIL (FOR MEN)	AEROSOL, FOAM		MINOXIDIL	Over-the-counter	—
209074-002	MINOXIDIL (FOR WOMEN)	AEROSOL, FOAM		MINOXIDIL	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 209074.
Type	No.	Action	Status	Date	Review
Supplement	9	Labeling	Approved	September 4, 2026	Standard
Supplement	3	Labeling	Approved	September 4, 2026	Standard
Supplement	2	Labeling	Approved	December 4, 2019	Standard
Supplement	1	Labeling	Approved	December 4, 2019	Standard
Original application	2		Approved	April 22, 2019	Standard
Original application	1		Approved	December 31, 2018	Standard

Review documents

0 · Original application · April 11, 2019
0 · Original application · January 22, 2019

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20221216). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20221216 HUMAN OTC DRUG · 20221216

Indications and Usage

openFDA Drug Labeling

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Purpose

openFDA Drug Labeling

Purpose Hair regrowth treatment for women

Dosage and Administration

openFDA Drug Labeling

Directions see enclosed leaflet for complete directions on how to use apply half a capful once daily directly to the scalp in the hair loss area massage into scalp with fingers, then wash hands well using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Warnings

openFDA Drug Labeling

Warnings For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. Do not use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all men. Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have heart disease

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months

Active Ingredient

openFDA Drug Labeling

Active ingredient Minoxidil 5% w/w (without propellant)

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
57483-530-31	57483-530	Innovus Pharmaceuticals, Inc.	3 CAN in 1 PACKAGE (57483-530-31) / 60 g in 1 CAN	November 12, 2019
57483-540-31	57483-540	Innovus Pharmaceuticals, Inc.	2 CAN in 1 PACKAGE (57483-540-31) / 60 g in 1 CAN	November 12, 2019
57483-530	57483-530	Innovus Pharmaceuticals, Inc.	—	January 2, 2019
57483-540	57483-540	Innovus Pharmaceuticals, Inc.	—	April 22, 2019

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
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.