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hair regrowth treatment

minoxidil · Solution

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
hair regrowth treatment
Generic name
minoxidil
Dosage form
Solution
Route
Topical
Marketing category
ANDA · ANDA
Labeler
CVS Pharmacy
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
10
Packages
15
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Minoxidil 2 g/100mL 645146 View
Minoxidil 5 g/100mL 645146 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Topical
Presentations
25

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
075598
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 13, 2001
Sponsor
PERRIGO
Products on application
1
Submissions recorded
5
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

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240820). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240820 HUMAN OTC DRUG · 20220224

Indications and Usage

openFDA Drug Labeling

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

Purpose Hair regrowth treatment for men

Dosage and Administration

openFDA Drug Labeling

Directions • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • 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. For use by men only. Flammable: Keep away from fire or flame Do not use if • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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 if • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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 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 2% w/v

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
72288-667-40 72288-667 Amazon.com Services LLC 6 BOTTLE in 1 CARTON (72288-667-40) / 60 mL in 1 BOTTLE (72288-667-00) September 3, 2026
69842-598-16 69842-598 CVS Pharmacy 1 BOTTLE, DROPPER in 1 CARTON (69842-598-16) / 60 mL in 1 BOTTLE, DROPPER May 21, 2021
69842-598-30 69842-598 CVS Pharmacy 3 BOTTLE, DROPPER in 1 CARTON (69842-598-30) / 60 mL in 1 BOTTLE, DROPPER May 21, 2021
69842-797-16 69842-797 CVS Pharmacy 1 BOTTLE, DROPPER in 1 CARTON (69842-797-16) / 60 mL in 1 BOTTLE, DROPPER December 22, 2021
69842-797-30 69842-797 CVS Pharmacy 3 BOTTLE, DROPPER in 1 CARTON (69842-797-30) / 60 mL in 1 BOTTLE, DROPPER December 30, 2021
30142-632-30 30142-632 Kroger Company 3 BOTTLE, DROPPER in 1 CARTON (30142-632-30) / 60 mL in 1 BOTTLE, DROPPER (30142-632-16) May 13, 2021
41250-428-30 41250-428 Meijer, Inc. 3 BOTTLE, DROPPER in 1 CARTON (41250-428-30) / 60 mL in 1 BOTTLE, DROPPER (41250-428-16) June 15, 2021
79481-0070-1 79481-0070 Meijer, Inc. 3 BOTTLE, DROPPER in 1 CARTON (79481-0070-1) / 60 mL in 1 BOTTLE, DROPPER (79481-0070-0) December 29, 2021
11822-1260-0 11822-1260 Rite Aid Corporation 1 BOTTLE, DROPPER in 1 CARTON (11822-1260-0) / 60 mL in 1 BOTTLE, DROPPER September 6, 2022
21130-611-16 21130-611 Safeway 1 BOTTLE in 1 CARTON (21130-611-16) / 60 mL in 1 BOTTLE August 13, 2024
21130-611-30 21130-611 Safeway 3 BOTTLE in 1 CARTON (21130-611-30) / 60 mL in 1 BOTTLE August 20, 2024
0363-0032-16 0363-0032 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0032-16) / 60 mL in 1 BOTTLE June 1, 2020
0363-0032-30 0363-0032 Walgreen Company 3 BOTTLE in 1 CARTON (0363-0032-30) / 60 mL in 1 BOTTLE June 1, 2020
0363-0703-16 0363-0703 Walgreen Company 1 BOTTLE, DROPPER in 1 CARTON (0363-0703-16) / 60 mL in 1 BOTTLE, DROPPER February 24, 2022
0363-0703-30 0363-0703 Walgreen Company 3 BOTTLE, DROPPER in 1 CARTON (0363-0703-30) / 60 mL in 1 BOTTLE, DROPPER February 17, 2022
72288-667 72288-667 Amazon.com Services LLC — September 3, 2026
69842-598 69842-598 CVS Pharmacy — May 21, 2021
69842-797 69842-797 CVS Pharmacy — December 22, 2021
30142-632 30142-632 Kroger Company — May 13, 2021
41250-428 41250-428 Meijer, Inc. — June 15, 2021
79481-0070 79481-0070 Meijer, Inc. — December 29, 2021
11822-1260 11822-1260 Rite Aid Corporation — August 23, 2022
21130-611 21130-611 Safeway — August 13, 2024
0363-0032 0363-0032 Walgreen Company — June 1, 2020
0363-0703 0363-0703 Walgreen Company — February 17, 2022

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 · 11 sections on this page.