Biofreeze

Product NDC: 59316-104
11-digit product format: 593160104
Labeler code: 59316
Product ID: 59316-104_51b427be-af9f-1fbe-e063-6394a90acada
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: 2010-11-01
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 100 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59316-104		D	Discontinued by firm	2026-10-15
excluded package	package	59316-104	59316-104-25	D	Discontinued by firm	2026-10-15
excluded package	package	59316-104	59316-104-50	D	Discontinued by firm	2026-10-15

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59316-104-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59316-104-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	59316-104-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	59316-104-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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	100 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
667889	Internal RxNorm lookup
1043232	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
5edddb99-6596-4a3b-b361-1cc04d032c31	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-104-10	Biofreeze	59 mL in 1 BOTTLE, SPRAY	SPRAY	59	40
59316-104-20	Biofreeze	118 mL in 1 BOTTLE, SPRAY	SPRAY	118	40
59316-104-25	Biofreeze	118 mL in 1 BOTTLE, SPRAY	SPRAY	118	40
59316-104-30	Biofreeze	473 mL in 1 BOTTLE, SPRAY	SPRAY	473	40

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
DIMETHYL SULFOXIDE	INACTIVE INGREDIENT	YOW8V9698H	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
JUNIPERUS COMMUNIS WHOLE	INACTIVE INGREDIENT	464910T5N9	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE (MENTHOL) SPRAY [PERFORMANCE HEALTH LLC]	24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-104	BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC]	38	Current NDC, Legacy NDC, 4 package rows	20240110_5edddb99-6596-4a3b-b361-1cc04d032c31.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 3 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine Plus	CALAMINE, PRAMOXINE HYDROCHLORIDE	Kroger Company	44fdd5a4-3cac-15e5-e063-6294a90adb52	2026-08-26	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief	LIDOCAINE	Cardinal Health, 110 dba LEADER	025d508b-ec4f-466c-b3e8-ba9b18d07b46	2026-08-26	Warnings	Exact identifier application number: M017
Inknows Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	59eb9c12-9e00-0171-e063-6394a90a8342	2026-08-25	Warnings	Exact identifier application number: M017
Lidomar	LIDOMAR	Oncora Pharma, LLC	215bfdca-60bf-480b-b02e-902de52fe5e8	2026-08-25	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	5f87d7fb-f258-48b0-8b60-1055e22ebd71	2026-08-25	Warnings	Exact identifier application number: M017
HEEL PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c7e13f-b9ea-023a-e063-6294a90a79e0	2026-08-24	Warnings	Exact identifier application number: M017
KNEE PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c8b33a-7d4f-2c6e-e063-6394a90a7929	2026-08-24	Warnings	Exact identifier application number: M017
Bovonte Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5958cc29-c449-56a7-e063-6394a90a960b	2026-08-24	Warnings	Exact identifier application number: M017
HUSTLE BUTTER NUMBING	LIDOCAINE HYDROCHLORIDE	H.B.D. D.I.S.T. INC.	d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e	2026-08-24	Warnings	Exact identifier application number: M017
JELVOXA NECK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a3d60a-26b5-e6a6-e063-6294a90a42bd	2026-08-22	Warnings	Exact identifier application number: M017
JELVOXA DMSO	CAMPHOR CAPSAICIN MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a43e2c-d258-34b5-e063-6394a90a09bf	2026-08-22	Warnings	Exact identifier application number: M017
Capsaicin 0.035 Percent	CAPSAICIN	Preferred Pharmaceuticals Inc.	0fabc025-4208-45f5-b3c2-543ae3a2df41	2026-08-21	Warnings	Exact identifier application number: M017
Claravie	HYDROCORTISONE ACETATE	Gentell LLC	598d224b-d12e-89bf-e063-6394a90a84dc	2026-08-21	Warnings	Exact identifier application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING	MENTHOL, CAMPHOR	Worldwide Cosmetics, Inc	3b8c2419-7a78-2731-e054-00144ff8d46c	2026-08-21	Warnings	Exact identifier application number: M017
PARCHE FRIO	METHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCH	DW SUPPORT LLC	5970a6f7-b273-9bb1-e063-6394a90afc79	2026-08-21	Warnings	Exact identifier application number: M017
Enokon Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	5976e667-e506-1d11-e063-6394a90a6809	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN TIGER Patch	TIGER PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5977cbb5-94c7-cb24-e063-6294a90a2e07	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN Nicotine Patches	NICOTINE PATCHES	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5978258a-549e-50e6-e063-6394a90a3d86	2026-08-20	Warnings	Exact identifier application number: M017
Claravie	CAMPHOR	Gentell LLC	5978bdab-5359-be9a-e063-6394a90a5a32	2026-08-20	Warnings	Exact identifier application number: M017
Rugby PAIN RELIEF PATCHES	LIDOCAINE	RUGBY LABORATORIES	b34e40c8-a257-46cf-9399-f55df9b4102d	2026-08-20	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
1043232	BIOFREEZE 10 % Topical Spray	PSN	5edddb99-6596-4a3b-b361-1cc04d032c31	40
667889	menthol 10 % Topical Spray	PSN	5edddb99-6596-4a3b-b361-1cc04d032c31	40
1043232	menthol 100 MG/ML Topical Spray [Biofreeze]	SBD	5edddb99-6596-4a3b-b361-1cc04d032c31	40
667889	menthol 100 MG/ML Topical Spray	SCD	5edddb99-6596-4a3b-b361-1cc04d032c31	40
1043232	Biofreeze 10 % Topical Spray	SY	5edddb99-6596-4a3b-b361-1cc04d032c31	40
1043232	Biofreeze 100 MG/ML Topical Spray	SY	5edddb99-6596-4a3b-b361-1cc04d032c31	40
667889	menthol 10 % Topical Spray	SY	5edddb99-6596-4a3b-b361-1cc04d032c31	40

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-104-10	59316010410	59 mL in 1 BOTTLE, SPRAY (59316-104-10)	59 ml	2016-08-25	0000-00-00	No	No	Current
59316-104-20	59316010420	118 mL in 1 BOTTLE, SPRAY (59316-104-20)	118 ml	2016-08-25	0000-00-00	No	No	Current
59316-104-25	59316010425	118 mL in 1 BOTTLE, SPRAY	118 ml					Historical
59316-104-30	59316010430	473 mL in 1 BOTTLE, SPRAY (59316-104-30)	473 ml	2016-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biofreeze Pain Relieving Spray	Reckitt Benckiser LLC \| Span Packaging Services LLC dba Multi-Pack Solutions	2026-05-13	HUMAN OTC DRUG LABEL	40