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	2026-10-16
excluded package	package	59316-104	59316-104-25	D	Discontinued by firm	2026-10-16
excluded package	package	59316-104	59316-104-50	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 · 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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gaayou Numbing	DIBUCAINE HYDROCHLORIDE 0.5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4c290118-7880-2a98-e063-6294a90a4c03	2026-07-21	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving Cold Gel	CAMPHOR, MENTHOL	Active and Innovative	572792bb-2819-36c3-e063-6394a90aa504	2026-07-21	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a36edc5-5a89-afb5-e063-6294a90a02dd	2026-07-21	Warnings	Exact identifier application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	Jiangxi Yudexi Pharmaceutical Co., LTD	4a45c1cb-c5ab-d872-e063-6394a90aab5d	2026-07-21	Warnings	Exact identifier application number: M017
SERYNTH Muscle Comfort	ARNICA MONTANA HPUS 7% MUSCLE COMFORT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c10cd-f0c4-8731-e063-6394a90a10a5	2026-07-21	Warnings	Exact identifier application number: M017
DERMFREE MEDICATED LIP	CAMPHOR 2.0% MEDICATED LIP	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d62fb-8dfa-404a-e063-6294a90a385d	2026-07-21	Warnings	Exact identifier application number: M017
NATUHEAL RELIEF Cream FOR ECZEMA	HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	4c92fed1-a8b4-bda8-e063-6394a90a8a33	2026-07-20	Warnings	Exact identifier application number: M017
REDCOOL Arnica Bruise	ARNICA MONTANA HPUS 7% ARNICA BRUISE	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	49911392-e55e-1a6b-e063-6394a90a9af0	2026-07-20	Warnings	Exact identifier application number: M017
Vamy HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	499197aa-f872-3abf-e063-6294a90aeda2	2026-07-20	Warnings	Exact identifier application number: M017
Subleef NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a201a6b-adde-c0a8-e063-6394a90a8285	2026-07-20	Warnings	Exact identifier application number: M017
PUVIDA NUMBING	MENTHOL 5% (W/W) NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4de4e317-2f4f-e5d6-e063-6394a90a0611	2026-07-20	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	8b607c03-a98f-445a-a69e-7625a76ac44b	2026-07-20	Warnings	Exact identifier application number: M017
Yodo Salil	OINTMENT	Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.	56812625-7eab-6a25-e063-6294a90a23fe	2026-07-20	Warnings	Exact identifier application number: M017
VBBV Numbing	LIDOCAINE	Jiashen International Trade Limited	5716c36b-6e97-c294-e063-6394a90aaf5c	2026-07-20	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	Premier Brands of America Inc.	560c29cc-2453-5d14-e063-6394a90a844f	2026-07-17	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	4981e9c3-2a19-aed8-e063-6294a90af216	2026-07-17	Warnings	Exact identifier application number: M017
endurance wipe	BENZOCAINE	Absorption Pharmaceuticals, LLC	303db1de-94fc-4543-e063-6294a90a01b9	2026-07-17	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare pain relieving gel Extra Strength	CAMPHOR, MENTHOL	Active and Innovative Inc.	56d30c33-ef5a-c63d-e063-6294a90acd29	2026-07-17	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Gel Alpine Fresh Scent	MENTHOL	Carlin Consumer Health LLC	56d3ca3d-21e1-a40a-e063-6294a90a9ff4	2026-07-17	Warnings	Exact identifier application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT Patch	MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b83ee8-8d86-9436-e063-6294a90a0c25	2026-07-16	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