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 25 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoTape	LIDOCAINE 4%	V2 Pharma LLC	ed18b4f7-6a2c-4dce-9b53-e485569093c5	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	4f112ab2-b67a-a3e2-e063-6394a90acb60	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	4f11aa1e-de53-a3b0-e063-6294a90a2fe4	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare 2X Medicated Pain Relief	LIDOCAINE, MENTHOL	Veridian Healthcare	4f11fca1-1949-ab8e-e063-6394a90ac627	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	4f125062-af89-40d3-e063-6394a90a27ef	2026-04-09	Warnings	Exact identifier application number: M017
DRMITSUI ECZEMA RELIEF	HYDROCORTISONE 1% ECZEMA RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4eee7637-3a28-e0bd-e063-6294a90ae1a4	2026-04-08	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR	Sinsin Pharmaceutical Co., Ltd.	47c077c2-6e34-8e7a-e063-6294a90a21b5	2026-04-08	Warnings	Exact identifier application number: M017
Yi Tiao Gen Pain Patch	PAIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	4828fe70-f6f8-45e4-9c9a-a9e486dc65e5	2026-04-07	Warnings	Exact identifier application number: M017
Dermatool Nerve Care	LIDOCAINE HCL, MENTHOL	Papalo Group, LLC	4ee40c96-9350-4c68-e063-6294a90ac812	2026-04-07	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	CVS Pharmacy, Inc.	42b3c341-f422-b2b4-e063-6294a90a47b2	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Pain Relieving Topical Analgesic	MENTHOL	Phoenix Bioperformance Products LLC	bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Anti-Inflammatory and Pain Relief	MENTHOL	Phoenix Bioperformance Products LLC	39a6d26b-b5f4-45d7-a9b5-6edbf42d7500	2026-04-06	Warnings	Exact identifier application number: M017
Dr. Blue PainZaway Pain Relieving Roll-On	MENTHOL	Indiana Botanic Gardens	4ecc8241-5a87-2f45-e063-6294a90aa30a	2026-04-06	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	CVS Pharmacy, Inc.	d7f52394-5cc1-48a6-ae89-9fc63b515758	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M017
Pain-Relieving Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4ecf4a6e-5c0f-7943-e063-6394a90a81cc	2026-04-06	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	RAPID AID VIET NAM COMPANY LIMITED	4edbaa1a-6e44-4865-e063-6394a90a8cc3	2026-04-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1% Cream	CAPSAICIN 0.1%	Puretek Corporation	4e83441b-cb6a-beb0-e063-6394a90a1b54	2026-04-03	Warnings	Exact identifier application number: M017
NeroCare Capsaicin Neuropathy Relief Cream	CAPSAICIN	Guangzhou Tata Biotechnology Co., Ltd.	4e89b7eb-0d84-dc57-e063-6394a90a7dd9	2026-04-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Patch	LIDOCAINE 4%	Veridian Healthcare	4e91da65-8191-6261-e063-6394a90a6bd5	2026-04-03	Warnings	Exact identifier application number: M017
HealthWise Roll-On	LIDOCAINE, MENTHOL	Veridian Healthcare	4e9306b5-949e-f7a9-e063-6394a90ae13a	2026-04-03	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