On this page

Minoxidil

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
Generic name
Minoxidil
Dosage form
Aerosol, Foam
Route
Topical
Marketing category
ANDA · ANDA
Labeler
P & L Development, LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
27
Packages
47
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 5 g/100g 645146 View
Minoxidil 50 mg/g 645146 View
Minoxidil 50 mg/mL 645146 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Aerosol, Foam
Route of administration
Topical
Presentations
74

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
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 20260806). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260806 HUMAN OTC DRUG · 20260303 HUMAN OTC DRUG · 20260303 HUMAN OTC DRUG · 20240517

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 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. 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 the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol, 5% (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 and pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 Aerosol, 5% (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 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 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
51316-212-03 51316-212 CVS Pharmacy 3 CAN in 1 CARTON (51316-212-03) / 60 g in 1 CAN August 19, 2022
51316-212-10 51316-212 CVS Pharmacy 1 CAN in 1 CARTON (51316-212-10) / 60 g in 1 CAN October 20, 2023
51316-212-30 51316-212 CVS Pharmacy 3 CAN in 1 CARTON (51316-212-30) / 60 g in 1 CAN August 19, 2022
51316-213-02 51316-213 CVS Pharmacy 2 CAN in 1 CARTON (51316-213-02) / 60 g in 1 CAN August 5, 2022
51316-213-10 51316-213 CVS Pharmacy 1 CAN in 1 CARTON (51316-213-10) / 60 g in 1 CAN October 20, 2023
84382-001-04 84382-001 Clarity Cosmetics Inc. 1 CAN in 1 PACKAGE (84382-001-04) / 60 g in 1 CAN June 1, 2026
70550-116-02 70550-116 Keranique 1 CAN in 1 PACKAGE (70550-116-02) / 60 g in 1 CAN March 15, 2024
70550-116-20 70550-116 Keranique 2 CAN in 1 PACKAGE (70550-116-20) / 60 g in 1 CAN March 15, 2024
59450-210-01 59450-210 Kroger Company 1 CAN in 1 CARTON (59450-210-01) / 60 g in 1 CAN October 18, 2022
59450-210-03 59450-210 Kroger Company 3 CAN in 1 CARTON (59450-210-03) / 60 g in 1 CAN October 18, 2022
59450-211-02 59450-211 Kroger Company 2 CAN in 1 CARTON (59450-211-02) / 60 g in 1 CAN (59450-211-01) October 18, 2022
0113-5129-01 0113-5129 L. Perrigo Company 60 g in 1 CAN (0113-5129-01) March 8, 2024
0113-5129-06 0113-5129 L. Perrigo Company 6 CAN in 1 CARTON (0113-5129-06) / 60 g in 1 CAN March 8, 2024
59726-115-60 59726-115 P & L Development, LLC 60 g in 1 CAN (59726-115-60) May 5, 2023
59726-115-65 59726-115 P & L Development, LLC 2 CAN in 1 PACKAGE (59726-115-65) / 60 g in 1 CAN May 5, 2023
59726-115-70 59726-115 P & L Development, LLC 3 CAN in 1 PACKAGE (59726-115-70) / 60 g in 1 CAN May 5, 2023
59726-116-60 59726-116 P & L Development, LLC 60 g in 1 CAN (59726-116-60) May 5, 2023
59726-116-65 59726-116 P & L Development, LLC 2 CAN in 1 PACKAGE (59726-116-65) / 60 g in 1 CAN May 5, 2023
59726-122-60 59726-122 P & L Development, LLC 1 CAN in 1 PACKAGE (59726-122-60) / 60 g in 1 CAN May 31, 2024
59726-125-60 59726-125 P & L Development, LLC 1 CAN in 1 PACKAGE (59726-125-60) / 60 mL in 1 CAN October 1, 2023
59726-125-70 59726-125 P & L Development, LLC 3 CAN in 1 PACKAGE (59726-125-70) / 60 mL in 1 CAN October 1, 2023
59726-151-60 59726-151 P & L Development, LLC 1 CAN in 1 PACKAGE (59726-151-60) / 60 g in 1 CAN July 1, 2024
59726-151-70 59726-151 P & L Development, LLC 3 CAN in 1 PACKAGE (59726-151-70) / 60 g in 1 CAN July 1, 2024
70550-605-04 70550-605 PROFECTUS BEAUTY LLC 1 CAN in 1 CARTON (70550-605-04) / 60 g in 1 CAN January 18, 2022
67438-015-00 67438-015 Padagis Israel Pharmaceuticals Ltd 60 g in 1 CAN (67438-015-00) March 1, 2012
82796-100-01 82796-100 RESTORATION HOLDINGS, LLC 1 CONTAINER in 1 BOX (82796-100-01) / 60 g in 1 CONTAINER January 1, 2023
69113-128-01 69113-128 SCIENTIFIC HAIR RESEARCH, LLC 1 CAN in 1 PACKAGE (69113-128-01) / 60 g in 1 CAN December 23, 2020
69113-128-03 69113-128 SCIENTIFIC HAIR RESEARCH, LLC 3 CAN in 1 PACKAGE (69113-128-03) / 60 g in 1 CAN December 23, 2020
69113-129-01 69113-129 SCIENTIFIC HAIR RESEARCH, LLC 1 CAN in 1 PACKAGE (69113-129-01) / 60 g in 1 CAN December 23, 2020
69113-129-02 69113-129 SCIENTIFIC HAIR RESEARCH, LLC 2 CAN in 1 PACKAGE (69113-129-02) / 60 g in 1 CAN December 23, 2020
82376-6006-3 82376-6006 SPAZI INC. 3 CAN in 1 CARTON (82376-6006-3) / 60 g in 1 CAN (82376-6006-8) August 30, 2022
82376-6007-2 82376-6007 SPAZI INC. 2 CAN in 1 CARTON (82376-6007-2) / 60 g in 1 CAN (82376-6007-8) August 30, 2022
51672-2128-4 51672-2128 Sun Pharmaceutical Industries, Inc. 1 CAN in 1 PACKAGE (51672-2128-4) / 60 g in 1 CAN January 2, 2019
51672-2128-9 51672-2128 Sun Pharmaceutical Industries, Inc. 3 CAN in 1 PACKAGE (51672-2128-9) / 60 g in 1 CAN January 2, 2019
51672-2129-4 51672-2129 Sun Pharmaceutical Industries, Inc. 1 CAN in 1 PACKAGE (51672-2129-4) / 60 g in 1 CAN April 22, 2019
51672-2129-8 51672-2129 Sun Pharmaceutical Industries, Inc. 2 CAN in 1 PACKAGE (51672-2129-8) / 60 g in 1 CAN April 22, 2019
11673-157-03 11673-157 TARGET Corporation 3 CAN in 1 CARTON (11673-157-03) / 60 g in 1 CAN (11673-157-01) August 16, 2022
11673-157-09 11673-157 TARGET Corporation 3 CAN in 1 CARTON (11673-157-09) / 60 g in 1 CAN (11673-157-01) August 16, 2022
11673-158-04 11673-158 TARGET Corporation 1 CAN in 1 CARTON (11673-158-04) / 60 g in 1 CAN August 16, 2022
11673-158-08 11673-158 TARGET Corporation 2 CAN in 1 CARTON (11673-158-08) / 60 g in 1 CAN August 16, 2022
71713-091-30 71713-091 Thirty MADISON, Inc. 3 CAN in 1 CARTON (71713-091-30) / 60 g in 1 CAN March 23, 2022
80855-201-05 80855-201 Virtue Labs, LLC 1 CAN in 1 PACKAGE (80855-201-05) / 60 g in 1 CAN December 23, 2020
80855-201-06 80855-201 Virtue Labs, LLC 2 CAN in 1 PACKAGE (80855-201-06) / 60 g in 1 CAN December 23, 2020
0363-9090-01 0363-9090 Walgreen Company 1 CAN in 1 CARTON (0363-9090-01) / 60 g in 1 CAN August 19, 2022
0363-9090-03 0363-9090 Walgreen Company 3 CAN in 1 CARTON (0363-9090-03) / 60 g in 1 CAN August 19, 2022
0363-9091-01 0363-9091 Walgreen Company 1 CAN in 1 CARTON (0363-9091-01) / 60 g in 1 CAN August 29, 2022
0363-9091-03 0363-9091 Walgreen Company 3 CAN in 1 CARTON (0363-9091-03) / 60 g in 1 CAN August 29, 2022
51316-212 51316-212 CVS Pharmacy — August 19, 2022
51316-213 51316-213 CVS Pharmacy — August 5, 2022
84382-001 84382-001 Clarity Cosmetics Inc. — June 1, 2026
70550-116 70550-116 Keranique — March 15, 2024
59450-210 59450-210 Kroger Company — October 18, 2022
59450-211 59450-211 Kroger Company — October 18, 2022
0113-5129 0113-5129 L. Perrigo Company — March 8, 2024
59726-115 59726-115 P & L Development, LLC — May 5, 2023
59726-116 59726-116 P & L Development, LLC — May 5, 2023
59726-122 59726-122 P & L Development, LLC — May 31, 2024
59726-125 59726-125 P & L Development, LLC — October 1, 2023
59726-151 59726-151 P & L Development, LLC — July 1, 2024
70550-605 70550-605 PROFECTUS BEAUTY LLC — January 18, 2022
67438-015 67438-015 Padagis Israel Pharmaceuticals Ltd — March 1, 2012
82796-100 82796-100 RESTORATION HOLDINGS, LLC — January 1, 2023
69113-128 69113-128 SCIENTIFIC HAIR RESEARCH, LLC — December 23, 2020
69113-129 69113-129 SCIENTIFIC HAIR RESEARCH, LLC — December 23, 2020
82376-6006 82376-6006 SPAZI INC. — August 30, 2022
82376-6007 82376-6007 SPAZI INC. — August 30, 2022
51672-2128 51672-2128 Sun Pharmaceutical Industries, Inc. — January 2, 2019
51672-2129 51672-2129 Sun Pharmaceutical Industries, Inc. — April 22, 2019
11673-157 11673-157 TARGET Corporation — August 16, 2022
11673-158 11673-158 TARGET Corporation — August 16, 2022
71713-091 71713-091 Thirty MADISON, Inc. — March 23, 2022
80855-201 80855-201 Virtue Labs, LLC — December 23, 2020
0363-9090 0363-9090 Walgreen Company — August 19, 2022
0363-9091 0363-9091 Walgreen Company — August 29, 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.