Biofreeze Professional Colorless

Product NDC: 59316-116
11-digit product format: 593160116
Labeler code: 59316
Product ID: 59316-116_51991b66-c6a4-c6d4-e063-6394a90a6f71
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-06-03
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 50 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59316-116	59316-116-11	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

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

Additional Listing Data#

Finished product: Yes
Brand name base: Biofreeze Professional Colorless
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	50 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
415975	Internal RxNorm lookup
1794892	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
4639201c-a67a-475f-8df6-3dc6225803ad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-116-10	Biofreeze Professional Colorless	89 mL in 1 BOTTLE	GEL	89	13
59316-116-11	Biofreeze Professional Colorless	3 mL in 1 PACKET	GEL	3	13
59316-116-20	Biofreeze Professional Colorless	118 mL in 1 TUBE	GEL	118	13
59316-116-40	Biofreeze Professional Colorless	946 mL in 1 BOTTLE	GEL	946	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-116-20	ML - Milliliter	59316-116	9f98ba32-1370-4a3c-9d30-553c5dce5d79	1	2024-03-12
59316-116-40	ML - Milliliter	59316-116	0d9c7bdf-1499-4bc4-bf40-881d50584007	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-116	BIOFREEZE PROFESSIONAL COLORLESS (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC]	12	Current NDC, Legacy NDC, 4 package rows	20241228_4639201c-a67a-475f-8df6-3dc6225803ad.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 1 of 154 · 3,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5911d9b0-1acb-3546-e063-6294a90adb3a	2026-08-15	Warnings	Exact identifier application number: M017
RVDU WARMING PAIN RELIEF	CAPSAICIN	QIRUI NETWORK (SHENZHEN) CO., LTD.	58eb2a86-bf25-d4b5-e063-6394a90af8c4	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care First Aid Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Nantong Health & Beyond Hygienic Products Inc.	c41621fb-c549-4394-a4cb-cb81ef8c98df	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	c88fa151-f8a8-4de2-98c9-71319bf53e36	2026-08-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Exact identifier application number: M017
CVS Pain Relief Roll-On Lidocaine with Lavender	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4aa53176-2103-b47b-e063-6394a90ac735	2026-08-12	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING	MENTHOL, CAMPHOR	Just Brands LLC	5384e80f-c242-76a1-e063-6294a90aba0b	2026-08-12	Warnings	Exact identifier application number: M017
RELIBONEOintment	TOPICAL ANALGESICOINTMENT	Guangdong Jiaoyu Biotechnology Co., Ltd	58ddaaf6-18ec-8c5b-e063-6294a90a2828	2026-08-12	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	58de3a29-2bec-6e44-e063-6394a90a9c1a	2026-08-12	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MUSCLE RUB	ALLIED TRADE LINK LLC	11d33e60-8c64-4316-a29a-d17e3e6e4a28	2026-08-11	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	58c2b35c-e1ed-7ea8-e063-6294a90a1494	2026-08-11	Warnings	Exact identifier application number: M017
Arctic Ice Pain Relieving Gel	MENTHOL	ONEST LIMITED	c63ef7a5-d649-4fba-9361-d37f1150e21d	2026-08-11	Warnings	Exact identifier application number: M017
Gee Gason	MALE GENITAL DESENSITIZER	Mon Gars Boutique Inc	58c75e5c-b801-017f-e063-6394a90a1c75	2026-08-11	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	58c84330-15bf-c397-e063-6394a90aba05	2026-08-11	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	TARGET Corporation	4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5	2026-08-11	Warnings	Exact identifier application number: M017
Medicated BODY	MENTHOL	CVS Pharmacy, Inc.	a0f61498-69c8-4ce0-bbd7-3a807f192d36	2026-08-11	Warnings	Exact identifier application number: M017
Muscle Move	MENTHOL	Saje Natural Wellness Inc.	526d3305-4cf8-2fc5-e063-6394a90ad53b	2026-08-10	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL	CVS Pharmacy	4aa629f5-8b8f-cc67-e063-6394a90a019f	2026-08-07	Warnings	Exact identifier application number: M017
Instant Cooling Itch Relief	HYDROCORTISONE	CVS Pharmacy	46545d04-5958-d136-e063-6394a90a3462	2026-08-07	Warnings	Exact identifier application number: M017
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE, ZINC ACETATE	CVS Pharmacy	46921bea-fcbe-94d6-e063-6394a90a726b	2026-08-07	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
1794892	BIOFREEZE 5 % Topical Gel	PSN	4639201c-a67a-475f-8df6-3dc6225803ad	13
415975	menthol 5 % Topical Gel	PSN	4639201c-a67a-475f-8df6-3dc6225803ad	13
1794892	menthol 0.05 MG/MG Topical Gel [Biofreeze]	SBD	4639201c-a67a-475f-8df6-3dc6225803ad	13
415975	menthol 0.05 MG/MG Topical Gel	SCD	4639201c-a67a-475f-8df6-3dc6225803ad	13
1794892	Biofreeze 5 % Topical Gel	SY	4639201c-a67a-475f-8df6-3dc6225803ad	13
415975	menthol 5 % Topical Gel	SY	4639201c-a67a-475f-8df6-3dc6225803ad	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-116-10	59316011610	89 mL in 1 BOTTLE (59316-116-10)	89 ml	2026-05-14		No	No	Current
59316-116-11	59316011611	3 mL in 1 PACKET	3 ml					Historical
59316-116-20	59316011620	118 mL in 1 TUBE (59316-116-20)	118 ml	2016-06-03	0000-00-00	No	No	Current
59316-116-40	59316011640	946 mL in 1 BOTTLE (59316-116-40)	946 ml	2016-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biofreeze Professional Colorless Gel	Reckitt Benckiser	2026-05-12	HUMAN OTC DRUG LABEL	13
Biofreeze Professional Colorless Gel	NuCare Pharmaceuticals,Inc.	2021-04-16	HUMAN OTC DRUG LABEL	3