Biofreeze Colorless Roll-On

Product NDC: 59316-206
11-digit product format: 593160206
Labeler code: 59316
Product ID: 59316-206_51b58e7e-a6c1-b40f-e063-6394a90a1f1e
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-17
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 40 mg/mL
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: Biofreeze Colorless Roll-On
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415974	Internal RxNorm lookup
1111683	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a8d59d45-0e85-43d1-affd-bbe922c4acb1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59316-206-10	Biofreeze Colorless Roll-On	1 in 1 CARTON	GEL	1		10
59316-206-10	Biofreeze Colorless Roll-On	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-206-10	ML - Milliliter	59316-206	7d320a39-8167-4221-b750-d09fba2f8683	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-206	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241228_a8d59d45-0e85-43d1-affd-bbe922c4acb1.zip

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 53 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Resinol	PETROLATUM AND RESORCINOL	ResiCal, Inc.	03f57a4a-f94b-4ba6-b709-41cfb6e16261	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Maximum Pain Relief	LIDOCAINE	Veridian Healthcare	afc3c16d-0076-44b2-ae7e-5f36d4d8088e	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Max Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	f39a27da-6799-4fc6-97ca-101eac4a9360	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Original Menthol	MENTHOL	Veridian Healthcare	e4bfb6b0-545e-4fbc-8538-4f41a6be1025	2025-12-17	Warnings	Exact identifier application number: M017
Welly Polka First Aid Kit	HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Dongguan Shenglian Tins Products Co., Ltd.	d7c4314c-c4c6-4adf-b384-3ac7a7108319	2025-12-17	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Arthritis Pain Therapy	MENTHOL	Wise Consumer Products	2410a199-f4a3-da6c-e063-6394a90aaace	2025-12-17	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE, MENTHOL	Vive Health LLC	462d3b24-643e-91da-e063-6394a90a0e1d	2025-12-17	Warnings	Exact identifier application number: M017
Teevodar Pain Relieving	MENTHOL	Sod-e Biotech Ltd	205b0fef-4f00-db2e-e063-6294a90a93b8	2025-12-17	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Arthritis Pain Relief	MENTHOL	WISE CONSUMER PRODUCTS CO.	116045df-891b-f370-e063-6294a90abe42	2025-12-17	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Intensive Foot Therapy	MENTHOL	Wise Consumer Products	23e56c6b-0f2b-721f-e063-6394a90a1ed0	2025-12-17	Warnings	Exact identifier application number: M017
Tiger Balm Ultra Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	f0561804-e0f7-495d-9768-9b86a208c51e	2025-12-17	Warnings	Exact identifier application number: M017
Kwan Loong	METHYL SALICYLATE AND MENTHOL	Haw Par Healthcare Ltd.	54bcb26e-786a-403e-9330-11ae9e3c013a	2025-12-17	Warnings	Exact identifier application number: M017
Magsoothium Body Cooling Formula	MENTHOL	Ubu/Elements, Inc.	f7fb6ac9-a920-a440-e053-6394a90aaa35	2025-12-16	Warnings	Exact identifier application number: M017
Magsoothium CBD Body Lavender	MENTHOL	Ubu/Elements, Inc.	f9b87fbe-b889-67a1-e053-6394a90acbcd	2025-12-16	Warnings	Exact identifier application number: M017
Aquaphor Itch Relief	HYDROCORTISONE	Beiersdorf Inc	b1d0333f-ba60-35d8-e053-2995a90af932	2025-12-16	Warnings	Exact identifier application number: M017
Magsoothium CBD Body	MENTHOL	Ubu/Elements, Inc.	00b2ef34-42d7-523c-e063-6294a90a753d	2025-12-16	Warnings	Exact identifier application number: M017
GENTLECARE HAND AND SKIN SANITIZER	BENZALKONIUM CHLORIDE	PARAGON SOLUTIONS US, INC.	16650277-fa62-485e-9a82-7763d2b50168	2025-12-16	Warnings	Exact identifier application number: M017
Welly First Aid Kit Refill	HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	Dongguan Shenglian Tins Products Co., Ltd.	4bc93855-4009-4b49-9fb4-e5864054153d	2025-12-16	Warnings	Exact identifier application number: M017
LidocainePain pain reliving gel-patch	PAIN RELIVING GEL-PATCH	Shenzhen Yuetai Electronic Commerce Co., Ltd	461ebbdd-0f26-a333-e063-6394a90a7a3e	2025-12-16	Warnings	Exact identifier application number: M017
Zestama	CAPSAICIN	V2 Pharma LLC	c9b46759-b8df-4ff4-815e-8e032c2635c0	2025-12-15	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111683	BIOFREEZE 4 % Topical Gel	PSN	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
415974	menthol 4 % Topical Gel	PSN	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
415974	menthol 0.04 MG/MG Topical Gel	SCD	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
1111683	Biofreeze 4 % Topical Gel	SY	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
415974	menthol 4 % Topical Gel	SY	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-206-10	59316020610	1 BOTTLE, WITH APPLICATOR in 1 CARTON (59316-206-10) / 89 mL in 1 BOTTLE, WITH APPLICATOR	2013-01-17	0000-00-00	No	No	Current