Biofreeze Colorless

Product NDC: 59316-103
11-digit product format: 593160103
Labeler code: 59316
Product ID: 59316-103_51b597cc-8068-e160-e063-6394a90ac1be
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: 2012-01-03
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 40 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 package	package	59316-103	59316-103-10	D	Discontinued by firm	2026-10-16
excluded package	package	59316-103	59316-103-11	D	Discontinued by firm	2026-10-16
excluded package	package	59316-103	59316-103-15	D	Discontinued by firm	2026-10-16
excluded package	package	59316-103	59316-103-28	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 · 48 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59316-103-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59316-103-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59316-103-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59316-103-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-103-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-103-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-103-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-103-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-103-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-103-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-103-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-103-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-103-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-103-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-103-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-103-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-103-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-103-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-103-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-103-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-103-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-103-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-103-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-103-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-103-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-103-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-103-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-103-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-103-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-103-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-103-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-103-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-103-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-103-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-103-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-103-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-103-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-103-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-103-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-103-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-103-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-103-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-103-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-103-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-103-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-103-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-103-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-103-15	`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 Colorless
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 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
415974	Internal RxNorm lookup
1111683	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
939dbbc3-71ec-4990-840e-7c9b8d430562	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-103-10	Biofreeze Colorless	5 mL in 1 BOTTLE	GEL	5	31
59316-103-11	Biofreeze Colorless	3 mL in 1 BOTTLE	GEL	3	31
59316-103-12	Biofreeze Colorless	89 mL in 1 BOTTLE	GEL	89	31
59316-103-15	Biofreeze Colorless	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	31
59316-103-20	Biofreeze Colorless	118 mL in 1 BOTTLE	GEL	118	31
59316-103-28	Biofreeze Colorless	273 mL in 1 BOTTLE	GEL	273	31
59316-103-40	Biofreeze Colorless	946 mL in 1 BOTTLE	GEL	946	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-103-12	ML - Milliliter	59316-103	b52397a8-ed9d-4dc6-b82e-39964b2d6c6a	1	2018-05-09
59316-103-20	ML - Milliliter	59316-103	700d69bb-759b-4ca7-941b-78f7b2225940	1	2024-06-10
59316-103-40	ML - Milliliter	59316-103	0770d763-3f20-4da3-91bb-9cc65a6fddcf	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE COLORLESS (MENTHOL) GEL [PERFORMANCE HEALTH LLC]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-103	BIOFREEZE COLORLESS (MENTHOL) GEL [RB HEALTH (US) LLC]	30	Current NDC, Legacy NDC, 7 package rows	20241228_939dbbc3-71ec-4990-840e-7c9b8d430562.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
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
1111683	BIOFREEZE 4 % Topical Gel	PSN	939dbbc3-71ec-4990-840e-7c9b8d430562	31
415974	menthol 4 % Topical Gel	PSN	939dbbc3-71ec-4990-840e-7c9b8d430562	31
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	939dbbc3-71ec-4990-840e-7c9b8d430562	31
415974	menthol 0.04 MG/MG Topical Gel	SCD	939dbbc3-71ec-4990-840e-7c9b8d430562	31
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	939dbbc3-71ec-4990-840e-7c9b8d430562	31
1111683	Biofreeze 4 % Topical Gel	SY	939dbbc3-71ec-4990-840e-7c9b8d430562	31
415974	menthol 4 % Topical Gel	SY	939dbbc3-71ec-4990-840e-7c9b8d430562	31
1111683	BIOFREEZE 4 % Topical Gel	PSN	cc1cba14-da40-4d7d-b522-b5c648798e96	4
415974	menthol 4 % Topical Gel	PSN	cc1cba14-da40-4d7d-b522-b5c648798e96	4
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	cc1cba14-da40-4d7d-b522-b5c648798e96	4
415974	menthol 0.04 MG/MG Topical Gel	SCD	cc1cba14-da40-4d7d-b522-b5c648798e96	4
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	cc1cba14-da40-4d7d-b522-b5c648798e96	4
1111683	Biofreeze 4 % Topical Gel	SY	cc1cba14-da40-4d7d-b522-b5c648798e96	4
415974	menthol 4 % Topical Gel	SY	cc1cba14-da40-4d7d-b522-b5c648798e96	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-103-10	59316010310	5 mL in 1 BOTTLE	5 ml					Historical
59316-103-11	59316010311	3 mL in 1 BOTTLE (59316-103-11)	3 ml	2012-01-03	2021-12-31	No	No	Current
59316-103-12	59316010312	89 mL in 1 BOTTLE (59316-103-12)	89 ml	2016-09-19	0000-00-00	No	No	Current
59316-103-15	59316010315	89 mL in 1 BOTTLE, WITH APPLICATOR	89 ml					Historical
59316-103-20	59316010320	118 mL in 1 BOTTLE (59316-103-20)	118 ml	2012-01-03	0000-00-00	No	No	Current
59316-103-28	59316010328	273 mL in 1 BOTTLE	273 ml					Historical
59316-103-40	59316010340	946 mL in 1 BOTTLE (59316-103-40)	946 ml	2012-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biofreeze ® Colorless	Reckitt Benckiser LLC	2026-05-13	HUMAN OTC DRUG LABEL	31
Biofreeze ® Colorless	A-S Medication Solutions	2024-11-11	HUMAN OTC DRUG LABEL	4
Biofreeze Colorless Gel	Performance Health LLC	2019-06-18	HUMAN OTC DRUG LABEL	3