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	2026-10-21
excluded package	package	59316-103	59316-103-11	D	Discontinued by firm	2026-10-21
excluded package	package	59316-103	59316-103-15	D	Discontinued by firm	2026-10-21
excluded package	package	59316-103	59316-103-28	D	Discontinued by firm	2026-10-21

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 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
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