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 61 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	fc8a8f20-97ab-481e-e053-6394a90a3525	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL	MENTHOL	SUNSET PAIN RELIEF ROLL-ON 3OZ	934d4638-b47b-187d-e053-2995a90ae69d	2025-11-20	Warnings	Exact identifier application number: M017
FOOT PAIN RELIEF ROLL-ON	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	43edcea0-ab04-f368-e063-6294a90a817a	2025-11-19	Warnings	Exact identifier application number: M017
Absolut Skin Corticosoothe Anti-Itch	HYDROCORTISONE	Absolut Skin Incorporated	deb52218-9176-4aaa-a22f-b66dada6690f	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	43f3d189-f6b7-02ed-e063-6394a90afd73	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2Z	LIDOCAINE	InterMed Laboratories Private Limited	43f3e288-e828-8130-e063-6394a90a6d44	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Leader	LIDOCAINE	InterMed Laboratories Private Limited	42f06914-c8b8-ea9c-e063-6294a90a79e6	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	CAMPHOR, MENTHOL	CVS	87715662-c788-9a8d-e053-2a95a90acb53	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti Itch	CAMPHOR, MENTHOL	Walgreens	b4f47a8d-d4a6-9233-e053-2a95a90afd90	2025-11-19	Warnings	Exact identifier application number: M017
Leader Anti-Itch	CAMPHOR, MENTHOL	LEADER/Cardinal Helath 110, Inc.	9ca985c6-5017-0558-e053-2995a90a8202	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	PRAMOXINE HCL	CVS	87fc476a-5b12-7383-e053-2995a90a530b	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti-Itch	PRAMOXINE HCL	Walgreens	b5f9d1c5-891e-4377-e053-2995a90aa281	2025-11-19	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	89f5f688-856f-f2df-e053-2995a90a73cf	2025-11-19	Warnings	Exact identifier application number: M017
Itch Eraser	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	2204e135-6a23-68a2-e063-6394a90ac019	2025-11-18	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	c8594e10-661f-6ff3-e053-2995a90ab4fc	2025-11-18	Warnings	Exact identifier application number: M017
Mag 5 PT Cooling Formula Recovery Cream	MENTHOL	RENU LABORATORIES, LLC	a45cde67-64ec-643b-e053-2a95a90a10b6	2025-11-18	Warnings	Exact identifier application number: M017
After Ivy Wipe	CAMPHOR	Tender Corporation d/b/a Adventure Ready Brands	21d98018-826a-1d0d-e063-6294a90a0a71	2025-11-17	Warnings	Exact identifier application number: M017
Itch Eraser Gel	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	223c7cfd-6dc5-140a-e063-6394a90a8332	2025-11-17	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Kroger Co.	6b3e7aac-395f-48cf-9c5e-f7e163724aef	2025-11-17	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	HY-VEE, INC	415ecfe9-3145-f23e-e063-6394a90adfd8	2025-11-17	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