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 39 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Easment advanced absorption cream	CAPSAICIN 0.1%	Easment LLC	48de3ced-f67f-7c86-e063-6294a90a340c	2026-01-20	Warnings	Exact identifier application number: M017
Black Cobra Tattoo NumbingSpray 4% Lidocaine	LIDOCAINE	Foshan Sugar Max Cosmetics CO.,Ltd	3605fcbf-63c8-87b5-e063-6294a90a9c3e	2026-01-19	Warnings	Exact identifier application number: M017
Black Cobra Tattoo Numbing Cream 4% Lidocaine	LIDOCAINE	Foshan Sugar Max Cosmetics CO.,Ltd	3605961a-d596-9c4a-e063-6394a90a99dc	2026-01-19	Warnings	Exact identifier application number: M017
Bakers Best Arthritis Pain Relief	HISTAMINE DIHYDROCHLORIDE	Baker's Best Health Products, LLC	869735f9-335e-4a5e-adfc-91167ae943c5	2026-01-19	Warnings	Exact identifier application number: M017
SIMPLY VITAL PAIN RELIEF HEMP	MENTHOL	ALPHA PLANTS INC	c14f4c06-cfe5-497e-9f9e-b2ba442e61bb	2026-01-19	Warnings	Exact identifier application number: M017
AsperFlex	MENTHOL AND METHYL SALICYLATE	Akron Pharma Inc.	117de175-976d-44f3-85ed-3d127fbe3a7c	2026-01-19	Warnings	Exact identifier application number: M017
Equate Pain Relieving Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	Wal-Mart Stores Inc	5ed1d7b3-925e-4a18-8e15-636f5b442ad7	2026-01-19	Warnings	Exact identifier application number: M017
Equate Medicated Pain Relieving Patch, Large 6-Count	CAMPHOR, MENTHOL, METHYL SALICYLATE	Walmart Stores Inc	2c25cd7a-7e7b-5add-e063-6294a90a9e9b	2026-01-19	Warnings	Exact identifier application number: M017
Equate Hydrocortione	1% HYDROCORTISONE	Walmart Inc.	85b7f620-cc95-4333-b124-bbcc8fd5f7eb	2026-01-19	Warnings	Exact identifier application number: M017
GuruNanda Pain Relief	MENTHOL	GURUNANDA, LLC	3f1d146e-0d18-7f2f-e063-6394a90ab816	2026-01-19	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine	LIDOCAINE	Chattem, Inc.	7ad8efa9-7031-4cd0-be1d-6dee63091fd1	2026-01-19	Warnings	Exact identifier application number: M017
Best Choice Targeted Warming Capsaicin Heat Patch	CAPSAICIN	Valu Merchandisers Company	24ca40b7-e17b-42a3-bcc8-6861b9a5934a	2026-01-18	Warnings	Exact identifier application number: M017
TOPCARE PAIN RELIEF PATCHES	LIDOCAINE	TOPCO ASSOCIATES, LLC	fa2f7768-e779-4409-aad3-6c33ce2e6b36	2026-01-18	Warnings	Exact identifier application number: M017
Neuropathy Pain Relief Cream	MENTHOL CREAM	Owell Naturals Brand, LLC	48979093-2992-5fd8-e063-6394a90a815d	2026-01-17	Warnings	Exact identifier application number: M017
CVS Lidocaine Pain Relief Cream	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	45c4f946-13b9-7a0a-e063-6394a90a7353	2026-01-16	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Cream	LIDOCAINE HCL 4%	Topco Associates, LLC	4885a7e6-a127-450a-e063-6294a90a4f91	2026-01-16	Warnings	Exact identifier application number: M017
Calmara	CALMARA	Dynarex Corporation	487393e9-6619-6033-e063-6294a90a68b2	2026-01-16	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone	HYDROCORTISONE OINTMENT	Walgreens	7088092c-3a5f-4fcc-84cc-931d238f7501	2026-01-15	Warnings	Exact identifier application number: M017
Itch Relief Gel	DIPHENHYDRAMINE HCL	Walgreens	487060a7-dff3-4840-b967-ca919f8d0a29	2026-01-15	Warnings	Exact identifier application number: M017
Walgreen Itch Relief Gel	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	5aca3297-406f-4165-9895-c58ccffb374f	2026-01-15	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