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Minoxidil
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Arteriolar Vasodilation [PE] | PE | All 29 members |
| Arteriolar Vasodilator [EPC] | EPC | All 29 members |
Regulatory status
Source: Drugs@FDANDC Directory| 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| 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 |
Prescribing information
Source: openFDA Drug LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUse to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Purpose
openFDA Drug LabelingPurpose Hair regrowth treatment for women
Dosage and Administration
openFDA Drug LabelingDirections • 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 LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk a doctor before use if you have heart disease
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredient Minoxidil 5% w/w (without propellant)
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.