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	2026-10-23
excluded package	package	59316-104	59316-104-25	D	Discontinued by firm	2026-10-23
excluded package	package	59316-104	59316-104-50	D	Discontinued by firm	2026-10-23

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 70 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aromalief Pain Relief Cream Orange Ginger	MENTHOL	Marketites LLC	9e8d3611-ef1b-4ac6-e053-2995a90af28a	2025-10-29	Warnings	Exact identifier application number: M017
Aromalief Calming Pain Relief Cream Lavender	MENTHOL	Marketites LLC	b8197d52-ccfb-b008-e053-2995a90a0a53	2025-10-29	Warnings	Exact identifier application number: M017
Aromalief Cozy Vanilla Pain Relief Cream	MENTHOL	Marketites LLC	3634e55e-8c62-a782-e063-6394a90a6508	2025-10-29	Warnings	Exact identifier application number: M017
BENOVA PAIN AND ITCH RELIEF	MENTHOL, 0.11%	BENOVA RX LLC	42513ee2-8b40-a9f3-e063-6394a90a9386	2025-10-29	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	CVS Pharmacy	7e9285fd-26d5-3eac-e053-2991aa0ae2db	2025-10-29	Warnings	Exact identifier application number: M017
Coralite Ultra Strength Pain Relief	CAMPHOR MENTHOL	United Exchange Corp.	44ecf959-cc07-4adc-a500-075b2ee69548	2025-10-29	Warnings	Exact identifier application number: M017
GoodSense Pain Relief	LIDOCAINE	Geiss, Destin & Dunn, Inc	826f8da4-8468-ea0a-e053-2991aa0a66cb	2025-10-28	Warnings	Exact identifier application number: M017
CALMADOL	CAMPHOR, MENTHOL, METHYL SALICYLATE	GRANDALL DISTRIBUTING, LLC	31b7f84e-8b66-4d31-8e9c-279d0af2fe64	2025-10-28	Warnings	Exact identifier application number: M017
XRay DOL	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	Genomma Lab USA, Inc.	e07fef46-68d9-769c-e053-2a95a90aa065	2025-10-28	Warnings	Exact identifier application number: M017
CVS Medicated Heat	CAPSICUM EXTRACT	CVS Pharmacy	81cd1019-93a6-311b-e053-2991aa0a7997	2025-10-28	Warnings	Exact identifier application number: M017
Foster and Thrive	LIDOCAINE	STRATEGIC SOURCING SERVICES, LLC	f950b072-d978-b629-e053-6394a90abfaf	2025-10-28	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Premier Brands of America, Inc.	d3452573-f91f-f157-e053-2a95a90a1ad8	2025-10-27	Warnings	Exact identifier application number: M017
PR	MENTHOL	Amphp, Inc	6f5b9e08-c445-4fac-e053-2a91aa0aa737	2025-10-27	Warnings	Exact identifier application number: M017
Lidocaine	BURN RELIEF	Foodhold USA	b25dc0df-02d0-41ac-b36c-2c04baa77ef2	2025-10-27	Warnings	Exact identifier application number: M017
Menthol	MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE	FSA Store Inc.	fb3548c8-f202-dc50-e053-6394a90a5b30	2025-10-27	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE CONTINUOUS SPRAY	Premier Brands of America, Inc.	d344f68b-9b62-3029-e053-2995a90a1665	2025-10-27	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1%	HYDROCORTISONE ACETATE 1%	Unifirst First Aid Corporation	f2b46d69-1c21-5ae9-e053-2a95a90a60a9	2025-10-24	Warnings	Exact identifier application number: M017
Extra Strength	MENTHOL AND METHYL SALICYLATE	Saje Natural Business Inc.	87d872b3-3231-d0f2-e053-2995a90a9d98	2025-10-24	Warnings	Exact identifier application number: M017
Coralite Muscle and Joint Pain Relief	CAMPHOR, MENTHOL, AND MEHTYL SALICYLATE	United Exchange Corporation	78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc	2025-10-24	Warnings	Exact identifier application number: M017
Coralite Odor Free Pain Relief	LIDOCAINE	United Exchange Corporation	7966d9f2-22f9-a900-e053-2991aa0aba55	2025-10-24	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