Drugplain

OpusMeds Extra Strength Minoxidil 50 mg/mL

MINOXIDIL · SOLUTION · Opus Meds LLC

No Recall History
Plain English

OpusMeds Extra Strength Minoxidil is a solution containing minoxidil at 50 mg/mL, taken topical. Manufactured by Opus Meds LLC.

Key Facts

Brand Name
OpusMeds Extra Strength Minoxidil
Generic Name
MINOXIDIL
NDC Code (Product)
87338-983
Manufacturer
Opus Meds LLC
Strength
50 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
ANDA076239
Drug Class
Arteriolar Vasodilator [EPC]
Marketing Start
01/06/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

adverse drug reaction8,500 reports
drug ineffective6,173 reports
application site pruritus2,521 reports
off label use1,425 reports
application site irritation1,212 reports
application site pain1,078 reports
headache1,061 reports
alopecia854 reports
application site dryness731 reports
inappropriate schedule of product administration728 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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. 5% minoxidil topical solution 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

Frequently Asked Questions

What is OpusMeds Extra Strength Minoxidil used for?

OpusMeds Extra Strength Minoxidil contains MINOXIDIL. It is a solution taken topical. Consult your doctor for specific uses.

Is OpusMeds Extra Strength Minoxidil a controlled substance?

OpusMeds Extra Strength Minoxidil is not classified as a controlled substance by the DEA.

What is the generic name for OpusMeds Extra Strength Minoxidil?

The generic name for OpusMeds Extra Strength Minoxidil is MINOXIDIL. There are 12 other brand versions of MINOXIDIL.

What is the NDC code for OpusMeds Extra Strength Minoxidil 50 mg/mL?

The NDC (National Drug Code) for OpusMeds Extra Strength Minoxidil 50 mg/mL is 87338-983, listed by Opus Meds LLC.