Biofreeze

Product NDC: 59316-101
11-digit product format: 593160101
Labeler code: 59316
Product ID: 59316-101_51b434c9-228b-2c05-e063-6394a90a1e94
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-08-25
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 35 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59316-101		D	Discontinued by firm	2026-10-12
excluded package	package	59316-101	59316-101-21	D	Discontinued by firm	2026-10-12
excluded package	package	59316-101	59316-101-25	D	Discontinued by firm	2026-10-12
excluded package	package	59316-101	59316-101-00	D	Discontinued by firm	2026-10-12

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59316-101-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59316-101-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59316-101-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59316-101-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59316-101-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59316-101-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59316-101-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59316-101-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59316-101-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59316-101-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59316-101-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59316-101-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59316-101-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59316-101-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59316-101-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59316-101-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59316-101-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59316-101-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59316-101-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59316-101-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59316-101-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59316-101-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59316-101-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59316-101-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59316-101-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59316-101-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59316-101-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59316-101-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59316-101-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59316-101-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59316-101-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59316-101-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59316-101-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59316-101-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59316-101-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59316-101-00	`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	35 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
808955	Internal RxNorm lookup
1043451	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
684faf63-5e44-4471-8384-e8fa7c0d842a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-101-10	Biofreeze	5 mL in 1 PACKET	GEL	5	43
59316-101-11	Biofreeze	30 mL in 1 BOTTLE	GEL	30	43
59316-101-12	Biofreeze	59 mL in 1 TUBE	GEL	59	43
59316-101-13	Biofreeze	59 mL in 1 BOTTLE, WITH APPLICATOR	GEL	59	43
59316-101-15	Biofreeze	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	43
59316-101-19	Biofreeze	3 mL in 1 PACKET	GEL	3	43
59316-101-20	Biofreeze	118 mL in 1 TUBE	GEL	118	43
59316-101-21	Biofreeze	81 mL in 1 TUBE	GEL	81	43
59316-101-25	Biofreeze	118 mL in 1 TUBE, WITH APPLICATOR	GEL	118	43
59316-101-30	Biofreeze	473 mL in 1 BOTTLE, PUMP	GEL	473	43
59316-101-40	Biofreeze	946 mL in 1 BOTTLE, PUMP	GEL	946	43
59316-101-50	Biofreeze	3785 mL in 1 BOTTLE, PUMP	GEL	3785	43

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
Menthol	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH LLC.]	32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-101	BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC]	42	Current NDC, Legacy NDC, 12 package rows	20241228_684faf63-5e44-4471-8384-e8fa7c0d842a.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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Overnight Roll-on	MENTHOL	Reckitt Benckiser LLC	f67d7b7a-8922-73f6-e053-2995a90a2e80	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Overnight Relief	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	07be6e88-1850-4d6a-946d-f03830b8c4a2	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Roll-On and Overnight Roll-On	MENTHOL	Reckitt Benckiser LLC	4d3dcb8f-2075-6bbc-e063-6394a90a4992	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Roll-On	MENTHOL	Reckitt Benckiser LLC	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Precision Relief Pen	MENTHOL	Reckitt Benckiser LLC	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	db982baf-31ea-4f09-90e3-cd5facb5dfe5	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional Roll-On	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	f62f8ec3-593d-480a-85a0-01fcd7f1790c	2026-05-15	Warnings	Exact identifier application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON	MENTHOL	Reckitt Benckiser LLC	8af185ad-719e-4684-89c0-9c17c1277499	2026-05-15	Warnings	Exact identifier application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVING	MENTHOL	Reckitt Benckiser LLC	ef158f63-2d75-47a3-b94a-2d821d511863	2026-05-15	Warnings	Exact identifier application number: M017
KY Duration for Him	LIDOCAINE	Reckitt Benckiser LLC	83cc86bd-3303-4956-a198-fae85b6e34e1	2026-05-15	Warnings	Exact identifier application number: M017
4% LIDOCAINE PATCHES	4% LIDOCAINE	Shenzhen Huayuan Hengsheng Technology Co., Ltd.	4f53cfd3-a7c4-e308-e063-6294a90ad698	2026-05-14	Warnings	Exact identifier application number: M017
Cold and Heat Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Cardinal Health, 110 dba LEADER	77066d01-75b0-4a8d-88d3-c639626d3326	2026-05-14	Warnings	Exact identifier application number: M017
Pain Relief Gel-Roll On	LIDOCAINE	Trifecta Pharmaceuticals USA	51cb6797-55ec-7a7a-e063-6294a90a90ee	2026-05-14	Warnings	Exact identifier application number: M017
Pain Relief Gel-Roll On	MENTHOL	Trifecta Pharmaceuticals USA	51b403dc-fc9b-0cad-e063-6394a90af081	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	5edddb99-6596-4a3b-b361-1cc04d032c31	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	684faf63-5e44-4471-8384-e8fa7c0d842a	2026-05-13	Warnings	Exact identifier application number: M017 ndc (product): 59316-101
Biofreeze	MENTHOL	Reckitt Benckiser LLC	4c798b06-6ee5-41d1-8a14-f6889512ade3	2026-05-13	Warnings	Exact identifier application number: M017
BIOFREEZE	MENTHOL	Reckitt Benckiser LLC	83d5c2f2-2413-4d28-83b2-0808d0917b4d	2026-05-13	Warnings	Exact identifier application number: M017
Scalpicin Anti-Itch Maximum Strength	HYDROCORTISONE	Reckitt Benckiser LLC	7b1a29fa-b266-43e6-a87b-aa3c96ab4041	2026-05-13	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
1043451	BIOFREEZE 3.5 % Topical Gel	PSN	684faf63-5e44-4471-8384-e8fa7c0d842a	43
808955	menthol 3.5 % Topical Gel	PSN	684faf63-5e44-4471-8384-e8fa7c0d842a	43
1043451	menthol 0.035 MG/MG Topical Gel [Biofreeze]	SBD	684faf63-5e44-4471-8384-e8fa7c0d842a	43
808955	menthol 0.035 MG/MG Topical Gel	SCD	684faf63-5e44-4471-8384-e8fa7c0d842a	43
1043451	Biofreeze 0.035 MG/MG Topical Gel	SY	684faf63-5e44-4471-8384-e8fa7c0d842a	43
1043451	Biofreeze 3.5 % Topical Gel	SY	684faf63-5e44-4471-8384-e8fa7c0d842a	43
808955	menthol 3.5 % Topical Gel	SY	684faf63-5e44-4471-8384-e8fa7c0d842a	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-101-10	59316010110	5 mL in 1 PACKET (59316-101-10)	5 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-11	59316010111	30 mL in 1 BOTTLE (59316-101-11)	30 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-12	59316010112	59 mL in 1 TUBE (59316-101-12)	59 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-13	59316010113	59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13)	59 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-15	59316010115	89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15)	89 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-19	59316010119	3 mL in 1 PACKET (59316-101-19)	3 ml	2022-01-01	0000-00-00	No	No	Current
59316-101-20	59316010120	118 mL in 1 TUBE (59316-101-20)	118 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-21	59316010121	81 mL in 1 TUBE	81 ml					Historical
59316-101-25	59316010125	118 mL in 1 TUBE, WITH APPLICATOR (59316-101-25)	118 ml	2016-08-25	2021-12-31	No	No	Current
59316-101-30	59316010130	473 mL in 1 BOTTLE, PUMP (59316-101-30)	473 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-40	59316010140	946 mL in 1 BOTTLE, PUMP (59316-101-40)	946 ml	2016-08-25	0000-00-00	No	No	Current
59316-101-50	59316010150	3785 mL in 1 BOTTLE, PUMP (59316-101-50)	3785 ml	2016-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biofreeze Pain Relieving Gel	Reckitt Benckiser LLC \| Span Packaging Services dba Multi-Pack Solutions	2026-05-13	HUMAN OTC DRUG LABEL	43