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 96 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Pain Relief	MENTHOL 10.5%	CVS	d0ea80ce-38b2-acde-e053-2995a90a47e5	2025-03-31	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	A2A Integrated Pharmaceuticals, LLC	31431866-6fb5-2acd-e063-6294a90ac520	2025-03-31	Warnings	Exact identifier application number: M017
Citrus Cleansing Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	f136616d-9f32-4e55-a495-b7466fd68526	2025-03-28	Warnings	Exact identifier application number: M017
Zpol ULTRA	MENTHOL, METHYL SALICYLATE	Laboratorios Zepol S.A.	1a1433a6-8d04-96df-e063-6394a90a987b	2025-03-27	Warnings	Exact identifier application number: M017
Muscle Recovery Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	1c347267-b653-41bf-9967-7feff17c38af	2025-03-27	Warnings	Exact identifier application number: M017
Soothing Lavender Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	ef26523a-b2f2-466e-89ad-f293cd64decb	2025-03-27	Warnings	Exact identifier application number: M017
Achelon Lidocaine Patch	LIDOCAINE PATCH 4%	Achelon, Inc	31408e21-e58d-6db5-e063-6294a90aa4bc	2025-03-26	Warnings	Exact identifier application number: M017
Achelon Lidocaine Patch	LIDOCAINE PATCH 4%	Achelon, Inc	3143bb72-2969-d66e-e063-6294a90a4604	2025-03-26	Warnings	Exact identifier application number: M017
Parche Leon	CAPSAICIN, CAMPHOR, MENTHOL	Pharmadel LLC	a8f266fa-6e43-559e-e053-2995a90a2c75	2025-03-26	Warnings	Exact identifier application number: M017
Adellina Numbing Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	314a83fe-8bdb-766f-e063-6294a90a61c6	2025-03-26	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Menthol Patch	LIDOCAINE AND MENTHOL	Veridian Healthcare	312f15fe-9297-2dc2-e063-6294a90a6f4d	2025-03-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	3130729d-1679-90cd-e063-6294a90a21e6	2025-03-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	31314dda-6199-574d-e063-6394a90aae7a	2025-03-25	Warnings	Exact identifier application number: M017
RWSEFK Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	31366793-f8a6-a2c4-e063-6294a90acbfc	2025-03-25	Warnings	Exact identifier application number: M017
Forticept Wounds and Burns Hydrogel	BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Lidan, inc.	c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f	2025-03-25	Warnings	Exact identifier application number: M017
MQ Pain Relieving Patch	PAIN RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0978ff22-c357-e266-e063-6394a90a98a4	2025-03-24	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Advanced Rx of Tennessee, LLC	30c97646-db06-df84-e063-6394a90a7743	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57	2025-03-20	Warnings	Exact identifier application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF	CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	5f904369-5f21-4907-98de-df23bce30823	2025-03-20	Warnings	Exact identifier application number: M017
DermaCort Anti-itch	HYDROCORTISONE	Melaleuca, Inc.	24044b0f-dd1e-4762-82b8-7a28b08c2f77	2025-03-20	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