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 84 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mountain Ice Sports Pain Relief	MENTHOL, CAMPHOR	Mountainside Medical Equipment, Inc.	c1f5512c-67b1-4ff0-b1a5-616e883d436f	2025-07-21	Warnings	Exact identifier application number: M017
Stopain Clinical Roll-On	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	27703209-fdac-4620-a445-d89a84bc853d	2025-07-21	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	9bac1869-8072-49bd-8568-a87a184d2200	2025-07-21	Warnings	Exact identifier application number: M017
Dr Kevin Khalili Pain Relief Cream	MENTHOL	DR. KHALILI LLC	3a79b38c-9adc-60dd-e063-6394a90a5b30	2025-07-21	Warnings	Exact identifier application number: M017
ARTHRITIS PAIN RELIEF	CAMPHOR, CAPSAICIN, METHYL SALICYLATE	YUNNAN BAIYAO GROUP CO., LTD.	671c57f0-3c6f-4416-bc81-f6930fef327b	2025-07-21	Warnings	Exact identifier application number: M017
GoodSense Cooling Pain Relief	MENTHOL	Geiss, Destin & Dunn, Inc	2e5e1375-df07-9a43-e063-6394a90a9938	2025-07-20	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Cooling	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	a7eae5dc-9db6-4bdf-9179-76060e75e044	2025-07-18	Warnings	Exact identifier application number: M017
Nicotine Patches	NICOTINE PATCHES	Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.	3a1abd26-c0aa-8a65-e063-6294a90ab66e	2025-07-17	Warnings	Exact identifier application number: M017
Aouiv 4% Lidocaine Numbing Cream	4% LIDOCAINE NUMBING CREAM	Guangzhou Qiexiran Cosmetics Co., Ltd.	3a221dd2-e945-bd0e-e063-6294a90a8fb9	2025-07-17	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	24538037-1d74-48a0-b909-98ecc57651fe	2025-07-17	Warnings	Exact identifier application number: M017
Hydrocortisone anti-itch plus	HYDROCORTISONE	Wal-Mart Stores, Inc.	a0c6e180-b385-4a9b-a9cf-84a551f533d0	2025-07-16	Warnings	Exact identifier application number: M017
OTC Rescue Lidocaine Pain Relief Patch	LIDOCAINE	Veridian Healthcare	0e742fc6-5f76-d202-e063-6394a90acf31	2025-07-16	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	ae4b7cd6-8b5d-4d25-86f9-72260638bb94	2025-07-16	Warnings	Exact identifier application number: M017
Freds Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	FRED'S, INC.	7502eebe-11c5-4e9e-b427-b87180a84349	2025-07-16	Warnings	Exact identifier application number: M017
PROINNATE Numbing Cream	MENTHOL	Guangzhou Haishi Biological Technology Co., Ltd.	39688b2b-c1fe-cd86-e063-6394a90a5345	2025-07-16	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	ViolaCare, Inc.	8f0ba6e7-8aa4-443e-99ae-a255085ddfec	2025-07-15	Warnings	Exact identifier application number: M017
TopCare Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Topco Associates LLC	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	2025-07-15	Warnings	Exact identifier application number: M017
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	TARGET Corporation	72c3889c-b743-4728-a315-6e4063e00200	2025-07-15	Warnings	Exact identifier application number: M017
Shopko Hydrocortisone Maximum Strength	HYDROCORTISONE	Shopko Stores Operating Co., LLC	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	2025-07-15	Warnings	Exact identifier application number: M017
Freds Hydrocortisone with Aloe	HYDROCORTISONE	FRED'S, INC.	076503bf-8238-4739-bb1c-c385e72f8a96	2025-07-15	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