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 46 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	ee8cd550-64ee-432e-98e5-b68083179a3c	2026-01-05	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	0eee554f-dfe0-433a-9665-8bdb95229888	2026-01-05	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	PAIN WIZARD LIMITED LIABILITY COMPANY	2647bba1-87f4-3c16-e063-6394a90ae0c9	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	efddd116-d753-425a-9ded-09b8045024e4	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Original Menthol	MENTHOL	Veridian Healthcare	ea56e4e1-a758-428b-8758-ee31bb00ca82	2026-01-05	Warnings	Exact identifier application number: M017
Mugwort Patch (Cervical spine use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e220c-0d35-9ee0-e063-6294a90ab689	2026-01-04	Warnings	Exact identifier application number: M017
Mugwort Patch (Lumbar spine use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e4b21-6d81-4cd3-e063-6394a90a18fe	2026-01-04	Warnings	Exact identifier application number: M017
Mugwort Patch (Knee use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e86d2-3030-91eb-e063-6394a90a4db0	2026-01-04	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	4a543f90-d43c-4487-b27e-f43394c6320d	2026-01-04	Warnings	Exact identifier application number: M017
Doctor Hoys Pain Relief Gel	MENTHOL, CAMPHOR (SYNTHETIC)	Dynamic Blending Specialists, Inc.	50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8	2026-01-02	Warnings	Exact identifier application number: M017
Doctor Hoys Pain Relief Gel Roll-On	MENTHOL, CAMPHOR (SYNTHETIC)	Dynamic Blending Specialists, Inc.	bf47acb2-6c90-4d5c-820b-447cac9305a4	2026-01-02	Warnings	Exact identifier application number: M017
Amino Rip Muscle Pain Relief	LIDOCAINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2bed5764-4217-4aa3-9d90-3b5460dcffa3	2026-01-02	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Village Pharma LLC	63bb0283-cfbe-4e9c-8772-73062c0c8d05	2026-01-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Village Pharma LLC	4c979a71-7c8f-4dff-abae-bf4cdf8f67b4	2026-01-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Village Pharma LLC	ffb7831f-4ca9-4d73-8303-e9cd90078982	2026-01-01	Warnings	Exact identifier application number: M017
Sting Relief	BENZOCAINE, ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co.,Ltd.	116ee6dc-9c49-2e11-e063-6394a90a44ed	2026-01-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Village Pharma LLC	48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13	2026-01-01	Warnings	Exact identifier application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVING	MENTHOL	JC SALES	5adf457e-b4d0-30c8-e063-6294a90a64b9	2026-01-01	Warnings	Exact identifier application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVING	MENTHOL	JC SALES	490bc3b1-48bf-5437-e063-6394a90a9018	2026-01-01	Warnings	Exact identifier application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVING	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	5ae00308-0a8c-065c-e063-6394a90aff6b	2026-01-01	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