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MINOXIDIL 5% (FOR WOMEN)

Minoxidil · Aerosol, Foam

Over-the-counter ANDA Official labelling
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 5% (FOR WOMEN)
Generic name
Minoxidil
Dosage form
Aerosol, Foam
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
6
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
8

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@FDANDC Directory
Application number
218616
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 22, 2024
Sponsor
AUROBINDO PHARMA
Products on application
2
Submissions recorded
1
Products approved under application 218616.
Product Trade name Form Strength Ingredient Status TE Flags
218616-001 MINOXIDIL (FOR MEN) AEROSOL, FOAM MINOXIDIL Over-the-counter —
218616-002 MINOXIDIL (FOR WOMEN) AEROSOL, FOAM MINOXIDIL Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 218616.
Type No. Action Status Date Review
Original application 1 Approved April 22, 2024 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260122). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260122

Indications and Usage

openFDA Drug Labeling

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

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 For external use only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Do not use if your degree of hair loss is different than that shown on side of this carton because this product may not work for you you have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth 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 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 6 months

Active Ingredient

openFDA Drug Labeling

Active ingredient Minoxidil USP 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
58602-104-23 58602-104 Aurohealth LLC 3 CAN in 1 CARTON (58602-104-23) / 60 g in 1 CAN June 19, 2026
58602-607-01 58602-607 Aurohealth LLC 1 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN April 22, 2024
58602-607-02 58602-607 Aurohealth LLC 2 CAN in 1 CARTON (58602-607-02) / 60 g in 1 CAN April 22, 2024
58602-607-03 58602-607 Aurohealth LLC 3 CAN in 1 CARTON (58602-607-03) / 60 g in 1 CAN April 22, 2024
58602-607-04 58602-607 Aurohealth LLC 4 CAN in 1 CARTON (58602-607-04) / 60 g in 1 CAN April 22, 2024
58602-607-05 58602-607 Aurohealth LLC 6 CAN in 1 CARTON (58602-607-05) / 60 g in 1 CAN April 22, 2024
58602-104 58602-104 Aurohealth LLC — June 19, 2026
58602-607 58602-607 Aurohealth LLC — April 22, 2024

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.