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QIDILA 5% Minoxidil foam

Minoxidil BIiotin · Aerosol, Foam

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

QIDILA 5% Minoxidil foam

Generic name

Minoxidil BIiotin

Dosage form

Aerosol, Foam

Route

Extracorporeal

Marketing category

ANDA · ANDA

Labeler

Beijing JUNGE Technology Co., Ltd.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Biotin	5 g/100mL	2707693	—
Minoxidil	5 g/100mL	645146	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Aerosol, Foam

Route of administration

Extracorporeal

Presentations

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@FDA NDC Directory

Application number

075357

Application type

ANDA · Abbreviated New Drug Application

Approval date

July 30, 1999

Sponsor

L PERRIGO CO

Products on application

Submissions recorded

Products approved under application 075357.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
075357-001	MINOXIDIL (FOR MEN)	SOLUTION		MINOXIDIL	Over-the-counter	—
075357-002	MINOXIDIL (FOR WOMEN)	SOLUTION		MINOXIDIL	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 075357.
Type	No.	Action	Status	Date	Review
Supplement	24	Labeling	Approved	March 30, 2016	Standard
Supplement	14	Labeling	Approved	October 8, 2008	—
Supplement	5	Labeling	Approved	July 14, 2005	—
Original application	1		Approved	July 30, 1999	—

Review documents

0 · Original application · July 21, 2015
0 · Original application · July 30, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250513). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250513

Indications and Usage

openFDA Drug Labeling

Use to regrow hair on the top of the scalp

Purpose

openFDA Drug Labeling

Hair regrowth treatment

Dosage and Administration

openFDA Drug Labeling

See enclosed leaflet for complete directions on how to use. Apply half a capful twice 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 regrowthor hair loss will begin again.

Warnings

openFDA Drug Labeling

For external use only. Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.

Do Not Use

openFDA Drug Labeling

your degree of hair loss is different than that shown on side of thiscarton because this product may not work for you. 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. Your hair loss is associated with childbirth. You are under 18 years of age, Do not use on babies and children, You use other medicines on the scalp. Your scalp is red, inflamed, infected, irritated, or painful.

Stop Use

openFDA Drug Labeling

if chest pain, rapid heartbeat, faintness, or dizziness occurs if sudden, unexplained weight gain occurs. if your hands or feet swell. if scalp irritation or redness occurs. if unwanted facial hair growth occurs . if you do not see hair regrowth in 6 months.

Active Ingredient

openFDA Drug Labeling

Minoxidil 5% Biotin 5%

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
85212-0002-1	85212-0002	Beijing JUNGE Technology Co., Ltd.	60 mL in 1 BOTTLE (85212-0002-1)	September 1, 2024
85212-0036-1	85212-0036	Beijing JUNGE Technology Co., Ltd.	60 mL in 1 BOTTLE, PUMP (85212-0036-1)	January 1, 2025
85212-0002	85212-0002	Beijing JUNGE Technology Co., Ltd.	—	September 1, 2024
85212-0036	85212-0036	Beijing JUNGE Technology Co., Ltd.	—	January 1, 2025

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 · 10 sections on this page.