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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4dfc77bb-11dd-e0f0-e063-6294a90a4e9c	2026-07-24	Warnings	Exact identifier application number: M017
DRAVYNOR QUIT SMOKING Patches	NICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5768631f-d517-5b43-e063-6294a90a8f46	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5b47ce-2bf1-42c7-e063-6294a90af09f	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE WART CORN REMOVER	SALICYLIC ACID 40% WART CORN REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c63b3-44de-8736-e063-6394a90ac21a	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE Anti-itch	HYDROCORTISONE1% ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5af4c6-555a-e74c-e063-6394a90aa6ce	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5d0e79-d620-0147-e063-6294a90a3103	2026-07-23	Warnings	Exact identifier application number: M017
MAG 5 PT WARMING FORMULA	MENTHOL	RENU LABORATORIES, LLC	a499ac9b-0e8e-e23f-e053-2a95a90abe9a	2026-07-23	Warnings	Exact identifier application number: M017
Icy Hot Performance Cream Pain Relief	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	73f7a113-ef11-4932-bf4d-4e62863f7941	2026-07-23	Warnings	Exact identifier application number: M017
Numbing Pain Relief	LIDOCAINE 4%	Walgreen Company	2425badb-e196-e9f8-e063-6294a90a7bf4	2026-07-22	Warnings	Exact identifier application number: M017
Cooling Pain Relief	MENTHOL 4.5%	Walgreen Company	24345ccf-c96f-31b0-e063-6294a90a82b5	2026-07-22	Warnings	Exact identifier application number: M017
Heat Pain Relief	CAPSAICIN 0.1%	Walgreen Company	2434f9cf-74aa-17af-e063-6294a90a56d9	2026-07-22	Warnings	Exact identifier application number: M017
Pain Relief Patch Lidocaine	LIDOCAINE	HyVee	41c26a66-3371-2c2c-e063-6294a90aa38b	2026-07-22	Warnings	Exact identifier application number: M017
CVS Ultra Strength Muscle	MENTHOL, CAMPHOR, METHYL SALICYLATE	CVS Pharmacy	48bef8bc-6e39-a328-e063-6394a90ae450	2026-07-22	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	daad9a1e-98d2-4ce7-9d97-ac5d81905abb	2026-07-22	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative	573c2d85-9e0b-7955-e063-6394a90aff64	2026-07-22	Warnings	Exact identifier application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF	BENZALKONIUM CHLORIDE, LIDOCAINE	Enviro Specialty Chemicals Inc	f7abe66c-dc2d-4ef7-9b11-5b87157fd302	2026-07-21	Warnings	Exact identifier application number: M017
Bclsks NUMBING	MENTHOL 1% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e26770-ddf6-7515-e063-6394a90a4ab3	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE21MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e9691-727f-6bcd-e063-6294a90aadfc	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE14MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5eec19-7f9a-d277-e063-6294a90ace95	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE7MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5f124e-2dd7-16b8-e063-6294a90a5cdb	2026-07-21	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
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