BIOFREEZE

Product NDC: 59316-102
Requested package NDC: 59316-102-11
11-digit product format: 593160102
Labeler code: 59316
Product ID: 59316-102_51b44481-a7ad-8a46-e063-6294a90aefda
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: 2012-01-03
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
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
83d5c2f2-2413-4d28-83b2-0808d0917b4d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-102-10	BIOFREEZE	5 mL in 1 BOTTLE	GEL	5	35
59316-102-11	BIOFREEZE	3 mL in 1 BOTTLE	GEL	3	35
59316-102-12	BIOFREEZE	89 mL in 1 BOTTLE	GEL	89	35
59316-102-15	BIOFREEZE	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	35
59316-102-16	BIOFREEZE	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	35
59316-102-20	BIOFREEZE	118 mL in 1 BOTTLE	GEL	118	35
59316-102-25	BIOFREEZE	118 mL in 1 BOTTLE, WITH APPLICATOR	GEL	118	35
59316-102-28	BIOFREEZE	237 mL in 1 BOTTLE	GEL	237	35
59316-102-30	BIOFREEZE	473 mL in 1 BOTTLE	GEL	473	35
59316-102-40	BIOFREEZE	946 mL in 1 BOTTLE	GEL	946	35
59316-102-50	BIOFREEZE	3785 mL in 1 CONTAINER	GEL	3785	35
59316-102-80	BIOFREEZE	44 mL in 1 TUBE	GEL	44	35
59316-102-90	BIOFREEZE	100 in 1 CARTON	GEL	100	35
59316-102-91	BIOFREEZE	10 in 1 CARTON	GEL	10	35
59316-102-92	BIOFREEZE	16 in 1 CARTON	GEL	16	35
59316-102-98	BIOFREEZE	30 mL in 1 BOTTLE	GEL	30	35
59316-102-80	Biofreeze	44 mL in 1 TUBE	GEL	44	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-102-12	ML - Milliliter	59316-102	8c11b8a5-4f02-41bf-88b6-e4af8c4214f8	1	2018-09-05
59316-102-20	ML - Milliliter	59316-102	63342204-7fd4-4732-9ec3-4df580a6e6ce	1	2015-06-09
59316-102-28	ML - Milliliter	59316-102	e8471990-bf89-42b8-8a43-721055ce7645	1	2018-09-05
59316-102-30	ML - Milliliter	59316-102	8537e275-8662-4f2c-ae52-44981681af99	1	2024-08-12
59316-102-40	ML - Milliliter	59316-102	030b1aca-eae8-43da-9839-6522c8c985ac	1	2024-08-12
59316-102-50	ML - Milliliter	59316-102	35b2fa59-5fb2-4779-a89d-b84cda167825	1	2024-08-12
59316-102-80	ML - Milliliter	59316-102	39ef3edc-90e7-4701-bbcc-add710ddea6d	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-102	BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC]	34	Current NDC, Legacy NDC, 16 package rows	20231114_83d5c2f2-2413-4d28-83b2-0808d0917b4d.zip
59316-102	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.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 · 3,115 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	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
415974	menthol 4 % Topical Gel	PSN	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
415974	menthol 0.04 MG/MG Topical Gel	SCD	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	Biofreeze 4 % Topical Gel	SY	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
415974	menthol 4 % Topical Gel	SY	83d5c2f2-2413-4d28-83b2-0808d0917b4d	35
1111683	BIOFREEZE 4 % Topical Gel	PSN	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
415974	menthol 4 % Topical Gel	PSN	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
415974	menthol 0.04 MG/MG Topical Gel	SCD	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
1111683	Biofreeze 4 % Topical Gel	SY	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1
415974	menthol 4 % Topical Gel	SY	f0c4d165-a242-4fb5-b2de-d64a825a29e9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-102-11	59316010211	3 mL in 1 BOTTLE (59316-102-11)	3 ml	2012-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BiOFREEZE ®	Reckitt Benckiser LLC	2026-05-13	HUMAN OTC DRUG LABEL	35
Biofreeze Gel	Performance Health LLC	2019-05-14	HUMAN OTC DRUG LABEL	3
Biofreeze Gel	Performance Health, LLC	2018-11-07	HUMAN OTC DRUG LABEL	1