Minoxidil Topical Solution

Product NDC: 87399-001
Requested package NDC: 87399-001-01
11-digit product format: 873990001
Labeler code: 87399
Product ID: 87399-001_4cd1163f-76c0-8700-e063-6294a90a3688
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil Topical Solution
Dosage form: LIQUID
Route: TOPICAL
Labeler: Growth Essence LLC
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-03-13
Substance: MINOXIDIL
Active strength: 2 g/100mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Minoxidil Topical Solution
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOXIDIL	2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5965120SH1	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4cd1163f-76bf-8700-e063-6294a90a3688	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil Topical Solution	MINOXIDIL TOPICAL SOLUTION	Growth Essence LLC	4cd1163f-76bf-8700-e063-6294a90a3688	2026-03-12	Warnings	Exact identifier ndc (package): 87399-001-01 ndc (product): 87399-001 ndc11 (package): 87399000101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5965120SH1	MINOXIDIL	38304-91-5	MINOXIDIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87399-001-01	87399000101	500 mL in 1 BOTTLE (87399-001-01)	500 ml	2026-03-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minoxidil Topical Solution	Growth Essence LLC \| Guangzhou Pallas Cosmetics Co.,Ltd.	2026-03-12	HUMAN OTC DRUG LABEL	1