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	2026-10-15
excluded package	package	59316-101	59316-101-21	D	Discontinued by firm	2026-10-15
excluded package	package	59316-101	59316-101-25	D	Discontinued by firm	2026-10-15
excluded package	package	59316-101	59316-101-00	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 · 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 44 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine HCI	LIDOCAINE HCI	Trifluent Pharma, LLC	47f7f06b-720e-eeec-e063-6294a90ae823	2026-01-09	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Bellus Medical, LLC	60cb89f6-e326-0773-e053-2a91aa0a33dd	2026-01-09	Warnings	Exact identifier application number: M017
Tetracaine	TETRACAINE	Bellus Medical, LLC	60cabb5f-606b-7a74-e053-2a91aa0ac024	2026-01-09	Warnings	Exact identifier application number: M017
Benzocaine	BENZOCAINE	Bellus Medical, LLC	60cafbaf-8ec6-46a5-e053-2a91aa0af11f	2026-01-09	Warnings	Exact identifier application number: M017
PRAX	PRAMOXINE HYDROCHLORIDE	AvPAK	dc646399-91ba-5cc1-e053-2a95a90a4f9c	2026-01-09	Warnings	Exact identifier application number: M017
2.5% Menthol PAIN RELIEF	MENTHOL	Universal Distribution Center LLC	c842544a-6aea-42af-a77e-7b202371b387	2026-01-09	Warnings	Exact identifier application number: M017
4% Menthol PAIN RELIEF	MENTHOL	Universal Distribution Center LLC	7fb95135-4151-4ef4-bb6d-75251cafff6c	2026-01-09	Warnings	Exact identifier application number: M017
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Meijer Distribution, Inc	781f89c0-94ab-48de-9e0b-decb37bcde46	2026-01-09	Warnings	Exact identifier application number: M017
LIDOCAINE PAIN RELIEVING Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2159fb73-cf6c-184a-e063-6394a90a1d14	2026-01-08	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Patch	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	22d9ce20-1cb6-c5bd-e063-6394a90a9eca	2026-01-08	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO INT'L THERMO ANALGETICS ROLL-ON	76ef713b-e23d-7b98-e053-2991aa0aad51	2026-01-08	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	bbf0ca84-2800-d222-e053-2995a90ad8f3	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	AvPAK	ef5b0db6-8f0a-4f8e-e053-2995a90a22b7	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin Topical Analgesic	CAPSAICIN	AvPAK	ef597423-cd01-7324-e053-2a95a90aa1ba	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin External Analgesic	CAPSAICIN	AvPAK	ef5a3846-1d2f-7023-e053-2a95a90ad716	2026-01-08	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	AvPAK	ef5bb0fa-afc2-62d7-e053-2a95a90a37f4	2026-01-08	Warnings	Exact identifier application number: M017
K2 Cold Therapy	MENTHOL	The Podiatree Co	60dce1ad-125e-396d-e053-2a91aa0a670f	2026-01-08	Warnings	Exact identifier application number: M017
Burn Relief Aloe	LIDOCAINE HCL	Acutens	48c435fe-2670-4b80-bf01-923dc9354422	2026-01-08	Warnings	Exact identifier application number: M017
Relieve A Pain	LIDOCAINE	Relieve A Pain LLC	cafaa830-d894-4590-8928-d579cc791d79	2026-01-08	Warnings	Exact identifier application number: M017
DZUL ARTHRITIS PAIN RELIEF	MENTHOL	Caball Sales, Inc.	159c301c-d462-bb2c-e063-6394a90a9e5a	2026-01-08	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