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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4dfc77bb-11dd-e0f0-e063-6294a90a4e9c	2026-07-24	Warnings	Exact identifier application number: M017
DRAVYNOR QUIT SMOKING Patches	NICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5768631f-d517-5b43-e063-6294a90a8f46	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5b47ce-2bf1-42c7-e063-6294a90af09f	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE WART CORN REMOVER	SALICYLIC ACID 40% WART CORN REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c63b3-44de-8736-e063-6394a90ac21a	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE Anti-itch	HYDROCORTISONE1% ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5af4c6-555a-e74c-e063-6394a90aa6ce	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5d0e79-d620-0147-e063-6294a90a3103	2026-07-23	Warnings	Exact identifier application number: M017
MAG 5 PT WARMING FORMULA	MENTHOL	RENU LABORATORIES, LLC	a499ac9b-0e8e-e23f-e053-2a95a90abe9a	2026-07-23	Warnings	Exact identifier application number: M017
Icy Hot Performance Cream Pain Relief	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	73f7a113-ef11-4932-bf4d-4e62863f7941	2026-07-23	Warnings	Exact identifier application number: M017
Numbing Pain Relief	LIDOCAINE 4%	Walgreen Company	2425badb-e196-e9f8-e063-6294a90a7bf4	2026-07-22	Warnings	Exact identifier application number: M017
Cooling Pain Relief	MENTHOL 4.5%	Walgreen Company	24345ccf-c96f-31b0-e063-6294a90a82b5	2026-07-22	Warnings	Exact identifier application number: M017
Heat Pain Relief	CAPSAICIN 0.1%	Walgreen Company	2434f9cf-74aa-17af-e063-6294a90a56d9	2026-07-22	Warnings	Exact identifier application number: M017
Pain Relief Patch Lidocaine	LIDOCAINE	HyVee	41c26a66-3371-2c2c-e063-6294a90aa38b	2026-07-22	Warnings	Exact identifier application number: M017
CVS Ultra Strength Muscle	MENTHOL, CAMPHOR, METHYL SALICYLATE	CVS Pharmacy	48bef8bc-6e39-a328-e063-6394a90ae450	2026-07-22	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	daad9a1e-98d2-4ce7-9d97-ac5d81905abb	2026-07-22	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative	573c2d85-9e0b-7955-e063-6394a90aff64	2026-07-22	Warnings	Exact identifier application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF	BENZALKONIUM CHLORIDE, LIDOCAINE	Enviro Specialty Chemicals Inc	f7abe66c-dc2d-4ef7-9b11-5b87157fd302	2026-07-21	Warnings	Exact identifier application number: M017
Bclsks NUMBING	MENTHOL 1% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e26770-ddf6-7515-e063-6394a90a4ab3	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE21MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e9691-727f-6bcd-e063-6294a90aadfc	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE14MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5eec19-7f9a-d277-e063-6294a90ace95	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE7MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5f124e-2dd7-16b8-e063-6294a90a5cdb	2026-07-21	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