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 65 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Knee Pain Relief Patch	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Shenzhen Finona Information Technology Co., Ltd	38755738-1a06-fdb4-e063-6294a90aa6eb	2025-11-12	Warnings	Exact identifier application number: M017
Recovery Numb	LIDOCAINE 4%	PURKLENZ FORMULATIONS INC.	e95e38e3-f743-4f5c-abdf-99ba6856e6f7	2025-11-12	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	434c13c2-52ee-000f-e063-6294a90af7e7	2025-11-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	434d5f92-05c2-d884-e063-6394a90ad28c	2025-11-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434df0be-49ff-aa56-e063-6394a90a3b5a	2025-11-11	Warnings	Exact identifier application number: M017
TopCare Pain Relief Maximum Strength	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES	b0ae3a7c-52d1-4923-bd50-6bb3749006c8	2025-11-11	Warnings	Exact identifier application number: M017
Comfortcaine	LIDOCAINE HCL	QS Key West Aloe, LLC	831b7c11-e437-4e74-808e-c9c1eb8b82f6	2025-11-11	Warnings	Exact identifier application number: M017
A and E Marathon Delay Serum	DELAY SERUM	Phe Inc	4355d1d8-44fe-aca1-e063-6294a90a85ff	2025-11-11	Warnings	Exact identifier application number: M017
A and E Deep Throat Desensitizing SprayStrawberry	ORAL NUMBING SPRAY STRAWBERRY	Phe Inc	4355dab1-a293-ded6-e063-6394a90af9b0	2025-11-11	Warnings	Exact identifier application number: M017
A and E Easy Anal Gel	ANAL NUMBING LUBRICANT	Phe Inc	4355e0f3-65ba-eca6-e063-6394a90ab43c	2025-11-11	Warnings	Exact identifier application number: M017
A and E Deep Throat Desensitizing SprayPeppermint	ORAL NUMBING SPRAY MINT	Phe Inc	4355e0d0-1222-d594-e063-6294a90abb29	2025-11-11	Warnings	Exact identifier application number: M017
DermaNumb Analgesic	LIDOCAINE HCL	A.T.S. Laboratories, LLC	0ea46890-45c3-4732-bc47-227f7c67daf1	2025-11-11	Warnings	Exact identifier application number: M017
Derma Numb Pain Relief	LIDOCAINE HCL	A.T.S. Laboratories, LLC	710991ae-8f82-4893-93a7-0ef3f815d132	2025-11-11	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Exact identifier application number: M017
Jelcaine Sterile	LIDOCAINE HCL JELLY USP, 2%	Brookfield Pharmaceuticals, LLC	1a39d1de-7aa2-3068-e063-6394a90aed85	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	c6e86a0f-6f9b-45b7-86ce-0bb1c198061a	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	97ae1993-7268-4b7f-92e2-6004337d5650	2025-11-10	Warnings	Exact identifier application number: M017
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	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