Biofreeze Roll-On

Product NDC: 59316-205
11-digit product format: 593160205
Labeler code: 59316
Product ID: 59316-205_51e07cc8-7357-2dce-e063-6394a90af835
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 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
ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59316-205-09	Biofreeze Roll-On	37 mL in 1 BOTTLE	GEL	37		21
59316-205-10	Biofreeze Roll-On	89 mL in 1 BOTTLE	GEL	89		21
59316-205-14	Biofreeze Roll-On	74 mL in 1 BOTTLE	GEL	74		21
59316-205-81	Biofreeze Roll-On	2 in 1 CARTON	GEL	2		21
59316-205-82	Biofreeze Roll-On	2 in 1 CARTON	GEL	2		21
59316-205-14	Biofreeze Roll-On and Overnight Roll-On	74 mL in 1 BOTTLE	GEL	74 mL	40 mg in 1mL	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-205-10	ML - Milliliter	59316-205	14d40e2b-5615-41bd-a594-c7c596c2427b	1	2024-06-10
59316-205-14	ML - Milliliter	59316-205	cd2e340d-0c11-4803-a4f5-ecfbd7e195ce	1	2022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE 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
59316-205	BIOFREEZE ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]	18	Current NDC, Legacy NDC, 5 package rows	20240323_ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb.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 1 of 156 · 3,119 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JenGufun LIDOCAINE KNEE Patch	LIDOCAINE KNEE PATCH	Henan Kangdi Medical Devices Co., Ltd.	5b1d8508-b993-7a8d-e063-6294a90ae306	2026-09-10	Warnings	Exact identifier application number: M017
Wart Corn Remover	SALICYLIC ACID	HONG KONG FOREVER YOUNG TRADING CO., LIMITED	5b0cd6e0-f220-4ebd-e063-6294a90ade67	2026-09-09	Warnings	Exact identifier application number: M017
Magic Cream	PAIN RELIEVING OINTMENT	Jiangxi Baikang Medical Products Co., Ltd.	5b0f2515-47e9-603f-e063-6294a90af9d4	2026-09-09	Warnings	Exact identifier application number: M017
Burn Gel	LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	e9d3e9be-1036-fad0-e053-2a95a90a6efe	2026-09-09	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	5b197cd8-542f-38b4-e063-6294a90ad7d3	2026-09-09	Warnings	Exact identifier application number: M017
Pain Relieving Lidocaine Patch	LIDOCAINE	YYBA CORP	af8c84fd-224c-72b3-e053-2a95a90a9568	2026-09-07	Warnings	Exact identifier application number: M017
American Safety First Aid	LIDOCAINE HCL	Orazen Inc	ea2f776b-dfd0-6ce4-e053-2995a90af009	2026-09-07	Warnings	Exact identifier application number: M017
MEDI-FIRST Topical Analgesic	LIDOCAINE HCI	Ultra Distributors Inc	b6f288f7-9ae3-215e-e053-2a95a90aedf6	2026-09-07	Warnings	Exact identifier application number: M017
MEDI-FIRST	BENZALKONIUM CHLORIDE, LIDOCAINE	Orazen Inc	f508434f-5948-7134-e053-2a95a90a03d7	2026-09-05	Warnings	Exact identifier application number: M017
MEDI-FIRST	BENZALKONIUM CHLORIDE, LIDOCAINE	Orazen Inc	f522fb0b-3d86-b228-e053-2a95a90a55e9	2026-09-05	Warnings	Exact identifier application number: M017
SurviveX Anti-itch Cream	SURVIVEX HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	5a7a1141-d3b1-0ee8-e063-6294a90a16aa	2026-09-04	Warnings	Exact identifier application number: M017
NeuroNesic Pain Relieving Cream	CAPSAICIN	Blaine Labs Inc.	7107c13d-bf59-4c0a-84fe-725a9fca2691	2026-09-04	Warnings	Exact identifier application number: M017
Neoteric Diabetic Skin Care 1 oz.	DIMETHICONE	RNA PHARMA LLC	5a944486-9591-f583-e063-6394a90aa04b	2026-09-03	Warnings	Exact identifier application number: M017
Equate Menthol Pain Relieving	MENTHOL	Wal-Mart Stores Inc	d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc	2026-09-03	Warnings	Exact identifier application number: M017
ZHI Technologies	LIDOCAINE, MENTHOL	ZHI Technologies, Inc.	6717e995-4d2d-49e8-8ecf-7c62557dfdef	2026-09-03	Warnings	Exact identifier application number: M017
Komxsum LIDOCAINE Cream	LIDOCAINE 4% CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9feae0-9be4-e736-e063-6294a90abe55	2026-09-03	Warnings	Exact identifier application number: M017
FREEZE EASE Roll-On	MENTHOL	Global America Group LLC	1869cc0d-a056-45de-aede-23b09b61ed12	2026-09-02	Warnings	Exact identifier application number: M017
Gaimoa Lidocaine Pain Relief Gel Patches	LIDOCAINE PAIN RELIEF GEL PATCHES	Henan Enokon Medical Instrument Co., Ltd.	5a68fe67-5c15-af9a-e063-6294a90a7ec1	2026-09-01	Warnings	Exact identifier application number: M017
CVS Cortisone Liquid	HYDROCORTISONE	CVS Pharmacy	42df45a9-d449-090a-e063-6394a90a9ee4	2026-09-01	Warnings	Exact identifier application number: M017
Ramedica Herbal Wonder Balm	CAMPHOR, MENTHOL	Ramedicare Sdn. Bhd.	cfb2ea0e-a1f6-4fdf-b866-346bbe78788f	2026-09-01	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	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
415974	menthol 4 % Topical Gel	PSN	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
415974	menthol 0.04 MG/MG Topical Gel	SCD	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
1111683	Biofreeze 4 % Topical Gel	SY	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
415974	menthol 4 % Topical Gel	SY	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	21
1111683	BIOFREEZE 4 % Topical Gel	PSN	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
415974	menthol 4 % Topical Gel	PSN	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
415974	menthol 0.04 MG/MG Topical Gel	SCD	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	Biofreeze 4 % Topical Gel	SY	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
415974	menthol 4 % Topical Gel	SY	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	BIOFREEZE 4 % Topical Gel	PSN	814b37ea-5441-4cec-8794-71ca01d849ae	3
415974	menthol 4 % Topical Gel	PSN	814b37ea-5441-4cec-8794-71ca01d849ae	3
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	814b37ea-5441-4cec-8794-71ca01d849ae	3
415974	menthol 0.04 MG/MG Topical Gel	SCD	814b37ea-5441-4cec-8794-71ca01d849ae	3
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	814b37ea-5441-4cec-8794-71ca01d849ae	3
1111683	Biofreeze 4 % Topical Gel	SY	814b37ea-5441-4cec-8794-71ca01d849ae	3
415974	menthol 4 % Topical Gel	SY	814b37ea-5441-4cec-8794-71ca01d849ae	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-205-09	59316020509	37 mL in 1 BOTTLE (59316-205-09)	37 ml	2024-03-15		No	No	Current
59316-205-10	59316020510	89 mL in 1 BOTTLE (59316-205-10)	89 ml	2013-01-17	0000-00-00	No	No	Current
59316-205-14	59316020514	74 mL in 1 BOTTLE (59316-205-14)	74 ml	2013-01-17	0000-00-00	No	No	Current
59316-205-81	59316020581	2 BOTTLE in 1 CARTON (59316-205-81) / 89 mL in 1 BOTTLE (59316-205-10)	2 bottle	2022-02-22	0000-00-00	No	No	Current
59316-205-82	59316020582	2 BOTTLE in 1 CARTON (59316-205-82) / 89 mL in 1 BOTTLE (59316-205-10)	2 bottle	2024-03-25		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biofreeze ® Roll-On	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	21
BioFreeze Day & Overnight Roll-On	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	5
Biofreeze ® Roll-On	A-S Medication Solutions	2023-10-30	HUMAN OTC DRUG LABEL	3
Biofreeze ® Roll-On	REMEDYREPACK INC.	2022-07-11	HUMAN OTC DRUG LABEL	8
Biofreeze Roll-On	REMEDYREPACK INC.	2019-02-12	HUMAN OTC DRUG LABEL	5