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 56 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HurriCaine One	TOPICAL ANESTHETIC AND ANTISEPTIC	Beutlich Pharmaceuticals LLC	459cedbd-9b6f-e450-e063-6394a90afb73	2025-12-10	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	45811e83-8d0b-bc2a-e063-6294a90adf50	2025-12-09	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	4580d7f0-92a9-d0d0-e063-6394a90ac393	2025-12-09	Warnings	Exact identifier application number: M017
LidoGuard	LIDOCAINE HCL	ALAINA HEALTHCARE PRIVATE LIMITED	c339dffe-bc9b-4fae-a50f-8db463d244c1	2025-12-09	Warnings	Exact identifier application number: M017
Capsaicin Cream 0.075%	CAPSAICIN	ALAINA HEALTHCARE PRIVATE LIMITED	33e861bd-bb92-4aea-9d4d-1b8847c794fd	2025-12-09	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	ALAINA HEALTHCARE PRIVATE LIMITED	e07c5ebc-5497-4c45-acc5-d12e72e98f3f	2025-12-09	Warnings	Exact identifier application number: M017
Ultra Strength Pain Relief Balm	CAMPHOR, MENTHOL	ALAINA HEALTHCARE PRIVATE LIMITED	80779d1f-0c2a-4ae5-9ed7-eb6877f734ba	2025-12-09	Warnings	Exact identifier application number: M017
Pain Relief Balm	MENTHOL AND CAMPHOR	ALAINA HEALTHCARE PRIVATE LIMITED	12d76b8f-4b1d-4f2d-9722-0adb55093cc4	2025-12-09	Warnings	Exact identifier application number: M017
Trojan Extended Pleasure	BENZOCAINE	Church & Dwight Co., Inc.	be731682-4174-649a-e053-2a95a90a3987	2025-12-09	Warnings	Exact identifier application number: M017
Stopain Clinical Continuous	MENTHOL	Troy Manufacturing, Inc.	65f8d212-0f0e-4893-b6af-bd68bba46443	2025-12-09	Warnings	Exact identifier application number: M017
Pain and Itch Relief 4% Lidocaine	LIDOCAINE	Walgreens	f84e76a9-6af6-4fd1-be4e-efa05728cbfd	2025-12-09	Warnings	Exact identifier application number: M017
Capsimide	CAPSAICIN 0.025% TOPICAL PATCH	Sola Pharmaceuticals	e81c2de8-6429-d681-e053-2995a90a36a9	2025-12-08	Warnings	Exact identifier application number: M017
Extra Strength Cold-Hot Medicated Patches	MENTHOL	Cardinal Health, 110 dba LEADER	a2895c03-747c-4220-8052-4f0428062622	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	5feae39e-3ab8-4cda-b9e8-dc221aea2417	2025-12-08	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	f8837b69-8d85-448c-a4b4-be911bca1f6c	2025-12-08	Warnings	Exact identifier application number: M017
CAPSAICIN HOT PATCHES	CAPSAICIN	Cardinal Health, 110 dba LEADER	76e6bc39-643c-4264-8d98-0e4fa7d778e2	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	3be6defd-f429-4dc7-8b37-5910705c0b81	2025-12-08	Warnings	Exact identifier application number: M017
LenzaPro Flex	LIDOCAINE/MENTHOL	SOLA Pharmaceuticals	ba498f1d-460b-f4e6-e053-2995a90a5755	2025-12-08	Warnings	Exact identifier application number: M017
LidaFlex	LIDOCAINE	SOLA Pharmaceuticals	b9e49529-13b4-1b0b-e053-2995a90adc7a	2025-12-08	Warnings	Exact identifier application number: M017
Rugby Menthol Hot Cold Patch	MENTHOL	RUGBY LABORATORIES	c68d29c2-9b56-4994-e053-2a95a90ae60e	2025-12-08	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