Over-the-counter medicine

Biotin and minoxidil

Biotin and minoxidil is an over-the-counter medicine. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed
Over the counter

Check it at the source: the biotin and minoxidil FDA label on DailyMed (effective August 27, 2026); every biotin and minoxidil label on DailyMed.

Highlights of the record

FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
to regrow hair on the top of the scalp

Forms and strengths

5 g/100ml / 5 g/100ml

Aerosol (foam).

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 1 under generic applications, 0 under brand applications, repackagers included; 8 more under the over-the-counter monograph, without an application

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 0 since 2020 0 Class I among all firms' recalls; 1 more by firms not listed as its makers

What is biotin and minoxidil used for?

From the label: indications and usage
to regrow hair on the top of the scalp

FDA pharmacologic class: Arteriolar Vasodilator.

Source: FDA drug label (MINOXIDIL 5% TOPICAL AEROSOL60g), Shenzhen Joyuflsh Technology Co.,Ltd., effective August 27, 2026 (SPL set 5a03675b-0bfd-7058-e063-6294a90acf4d), via openFDA; the full label on DailyMed

Is there a generic for biotin and minoxidil?

No generic biotin and minoxidil is approved (Drugs@FDA, October 8, 2026).

FDA's NDC Directory lists biotin and minoxidil from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has biotin and minoxidil been recalled?

The FDA's Enforcement Report lists 1 recall naming biotin and minoxidil since 2020: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of biotin and minoxidil and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
July 2, 2020	Class II	MasterPharm LLC not a listed maker	Lack of Processing Controls (lack of assurance of conformity to specifications).

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What next?

Other arteriolar vasodilators: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other