Biofreeze

Product NDC: 59316-114
11-digit product format: 593160114
Labeler code: 59316
Product ID: 59316-114_51b43faa-c82a-4053-e063-6294a90a3c20
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: SPRAY
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-19
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 105 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59316-114	59316-114-50	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	105 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
1489073	Internal RxNorm lookup
1489074	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
4c798b06-6ee5-41d1-8a14-f6889512ade3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-114-10	Biofreeze	89 mL in 1 BOTTLE	SPRAY	89	21
59316-114-25	Biofreeze	118 mL in 1 BOTTLE, SPRAY	SPRAY	118	21
59316-114-30	Biofreeze	473 mL in 1 BOTTLE, SPRAY	SPRAY	473	21
59316-114-50	Biofreeze	1 mL in 1 PACKET	SPRAY	1	21
59316-114-50	Biofreeze	10 in 1 BOX	SPRAY	10	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-114-10	ML - Milliliter	59316-114	34d03209-6552-449d-85d4-80c703287948	1	2018-09-05
59316-114-25	ML - Milliliter	59316-114	cf2515ba-bce7-4676-bd56-90f07f8450f7	1	2024-08-12
59316-114-30	ML - Milliliter	59316-114	18baaf7f-09d9-4346-8fb2-3dbcf47bf5a1	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
BERRY	INACTIVE INGREDIENT	FV3431923Z	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
JUNIPERUS COMMUNIS WHOLE	INACTIVE INGREDIENT	464910T5N9	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-114	BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC]	20	Current NDC, Legacy NDC, 5 package rows	20241228_4c798b06-6ee5-41d1-8a14-f6889512ade3.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 6 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non-proprietary name	HEADACHE PATCH	Nanjing 3H Medical Products Co.,Ltd.	586d73f1-0b0b-f596-e063-6394a90a4d57	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Dealmed Burn	LIDOCAINE	Dealmed Medical Supplies, LLC.	3b5f7ded-c275-4d7f-9fd4-539797d5507e	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
Hempe HOT Muscle and Joint Gel	HEMPE	Healthcare International Research Limited	5854a80e-c92b-3ff5-e063-6294a90a2d05	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine Plantar Relief Roll-On	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	585ccb4b-3bff-39b9-e063-6294a90a0e18	2026-08-05	Warnings	Exact identifier application number: M017
Green MARVEL PAIN RELIEF	MENTHOL, CAMPHOR, METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	9ff6e477-ef79-4a0c-9e21-8cae0e5d8810	2026-08-05	Warnings	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Wini By Locsanity Advanced Formula Muscle Joint Relief Balm	METHYL SALICYLATE,CAMPHOR,MENTHOL	Locsanity LLC	5829b5d7-78d4-78a2-e063-6394a90a3dfc	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	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
1489074	BIOFREEZE 10.5 % Topical Spray	PSN	4c798b06-6ee5-41d1-8a14-f6889512ade3	21
1489073	menthol 10.5 % Topical Spray	PSN	4c798b06-6ee5-41d1-8a14-f6889512ade3	21
1489074	menthol 105 MG/ML Topical Spray [Biofreeze]	SBD	4c798b06-6ee5-41d1-8a14-f6889512ade3	21
1489073	menthol 105 MG/ML Topical Spray	SCD	4c798b06-6ee5-41d1-8a14-f6889512ade3	21
1489074	Biofreeze 10.5 % Topical Spray	SY	4c798b06-6ee5-41d1-8a14-f6889512ade3	21
1489074	Biofreeze 105 MG/ML Topical Spray	SY	4c798b06-6ee5-41d1-8a14-f6889512ade3	21
1489073	menthol 10.5 % Topical Spray	SY	4c798b06-6ee5-41d1-8a14-f6889512ade3	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-114-10	59316011410	89 mL in 1 BOTTLE (59316-114-10)	89 ml	2016-09-19	0000-00-00	No	No	Current
59316-114-25	59316011425	118 mL in 1 BOTTLE, SPRAY (59316-114-25)	118 ml	2014-02-19	0000-00-00	No	No	Current
59316-114-30	59316011430	473 mL in 1 BOTTLE, SPRAY (59316-114-30)	473 ml	2014-02-19	0000-00-00	No	No	Current
59316-114-50	59316011450	10 PACKET in 1 BOX (59316-114-50) > 1 mL in 1 PACKET	10 packet	2014-02-19	2021-12-31	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	21
Biofreeze Spray	Performance Health LLC	2019-06-18	HUMAN OTC DRUG LABEL	6