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 81 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LILAS PERIOD	MENTHOL	Lilas Wellness, Inc.	5ea53b4b-45e6-48a7-8090-09c3a21e7f63	2025-08-11	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Roll-On	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	31639407-0f11-bde2-e063-6294a90af694	2025-08-10	Warnings	Exact identifier application number: M017
Chinese Red Tiger Lidocaine Patches	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	20cd369c-3e98-3d8f-e063-6394a90a0824	2025-08-10	Warnings	Exact identifier application number: M017
Treatonic LIDOCAINE PAIN RELIEF	LIDOCAINE 4%	100 KARMA INC	3bd66b03-ac82-2d45-e063-6294a90a610a	2025-08-08	Warnings	Exact identifier application number: M017
Capsaicin 0.025%	CAPSAICIN 0.025%	Advanced Rx of Tennessee, LLC	3bdcef94-d06f-9152-e063-6294a90a6072	2025-08-08	Warnings	Exact identifier application number: M017
MENTHOL 5%	MENTHOL 5%	Advanced Rx of Tennessee, LLC	3bdd0c52-29d8-ab67-e063-6294a90a9c45	2025-08-08	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	Advanced Rx of Tennessee, LLC	3bdd3015-349a-0fac-e063-6394a90afe41	2025-08-08	Warnings	Exact identifier application number: M017
LIDOCAINE 4%	LIDOCAINE 4%	Advanced Rx of Tennessee, LLC	3bdd6b3d-7180-288c-e063-6394a90a1785	2025-08-08	Warnings	Exact identifier application number: M017
Good Sense Pain Relief Roll On	LIDOCAINE HCL	Geiss, Destin & Dunn, Inc	38e76fd6-e5fb-493c-e063-6294a90afed4	2025-08-08	Warnings	Exact identifier application number: M017
Aruba Aloe Alcoholada	LIDOCAINE HYDROCHLORIDE	Aruba Aloe Balm NV	f56c62b0-75db-4499-858e-54e10b0e140a	2025-08-07	Warnings	Exact identifier application number: M017
SurviveX Hydrocortisone Cream	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	3bd1da8d-5142-798c-e063-6294a90a7be6	2025-08-07	Warnings	Exact identifier application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGE	SOOTHING PAIN RELIEF MASSAGE	Beijing JUNGE Technology Co., Ltd.	3524ad62-0ed6-f2e5-e063-6394a90a3283	2025-08-06	Warnings	Exact identifier application number: M017
Alumier MD Intensive Recovery	HYDROCORTISONE	Alumier Labs	d9b79ea1-6558-543c-e053-2995a90ae53e	2025-08-06	Warnings	Exact identifier application number: M017
Good Neighbor Roll-on Pain Relief	LIDOCAINE HCL	Amerisource Bergen	a0c3adbf-fa35-47c0-9db3-459ce9a106ac	2025-08-06	Warnings	Exact identifier application number: M017
Good Neighbor Roll-on Menthol Pain Relief Gel	MENTHOL	Amerisource Bergen	bd557323-0003-4ee6-b22d-a72d621c7de4	2025-08-05	Warnings	Exact identifier application number: M017
Earthmed FS Pain relieving balm	MENTHOL	Earthmed LLC	3ba4e769-fec6-52d9-e063-6394a90a65d4	2025-08-05	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	HF Acquisition Co LLC, DBA HealthFirst	3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6	2025-08-05	Warnings	Exact identifier application number: M017
Kocowo Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	3b82989d-7cc3-23d3-e063-6294a90ae2a3	2025-08-03	Warnings	Exact identifier application number: M017
Menthol pain relief patches	MENTHOL	Menthol pain relief patch	3b5fd718-3f86-f7a7-e063-6294a90a8c52	2025-08-02	Warnings	Exact identifier application number: M017
Graphene Far Infrared Herbal Pain Relief Patches	CORYDALIS RHIZOME	Changsha Maocheng Trading Co., Ltd	3b604a3c-fe91-7096-e063-6394a90afe04	2025-08-02	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