5% Minoxidil Hair Growth Foam with Biotin

Product NDC: 85304-016
11-digit product format: 853040016
Labeler code: 85304
Product ID: 85304-016_3e5595a6-b36f-2567-e063-6294a90a2078
Type: HUMAN OTC DRUG
Nonproprietary name: Minoxidil
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Guangzhou Borderless Technology Co., Ltd.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-09-09
Substance: BIOTIN; MINOXIDIL
Active strength: .5; 5 g/100mL; g/100mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
BIOTIN	.5 g/100mL
MINOXIDIL	5 g/100mL

Field, Values table
Field	Values
Unii	6SO6U10H04, 5965120SH1
Rxcui	2723100

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85304-016-01	5% Minoxidil Hair Growth Foam with Biotin	80 mL in 1 BOTTLE	AEROSOL, FOAM	80	1
85304-016-01	5% Minoxidil Hair Growth Foam with Biotin	3 in 1 PACKAGE	AEROSOL, FOAM	3	1
85304-016-02	5% Minoxidil Hair Growth Foam with Biotin	6 in 1 PACKAGE	AEROSOL, FOAM	6	1
85304-016-02	5% Minoxidil Hair Growth Foam with Biotin	80 mL in 1 BOTTLE	AEROSOL, FOAM	80	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6SO6U10H04	BIOTIN	58-85-5	BIOTIN
5965120SH1	MINOXIDIL	38304-91-5	MINOXIDIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2723100	biotin 0.5 % / minoxidil 5 % Topical Foam	PSN	3e5595a6-b36e-2567-e063-6294a90a2078	1
2723100	biotin 5 MG/ML / minoxidil 50 MG/ML Topical Foam	SCD	3e5595a6-b36e-2567-e063-6294a90a2078	1
2723100	biotin 0.5 % / minoxidil 5 % Topical Foam	SY	3e5595a6-b36e-2567-e063-6294a90a2078	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85304-016-01	85304001601	3 BOTTLE in 1 PACKAGE (85304-016-01) / 80 mL in 1 BOTTLE	3 bottle	2025-09-09	No	No	Current
85304-016-02	85304001602	6 BOTTLE in 1 PACKAGE (85304-016-02) / 80 mL in 1 BOTTLE	6 bottle	2025-09-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
85304-016 5% Minoxidil Hair Growth Foam with Biotin	Guangzhou Borderless Technology Co., Ltd.	2025-09-08	HUMAN OTC DRUG LABEL	1