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		2026-10-21

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 · 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…`

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 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 28 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a33f9a9-1fdc-7cdf-e063-6294a90adca1	2026-03-25	Warnings	Exact identifier application number: M017
EjaGuard	LIDOCAINE	MOLANSPACE INC	475f64ef-d636-7e87-e063-6294a90ae32f	2026-03-25	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	ProStat First Aid	4e53d29c-ed3c-f481-e063-6294a90a3181	2026-03-25	Warnings	Exact identifier application number: M017
Topicaine Ultra	TOPICAINE ULTRA	Oncora Pharma, LLC	e052f718-700a-44e0-8770-65451b812ee1	2026-03-24	Warnings	Exact identifier application number: M017
Hot Pap Cataplasma	METHYL SALICYLATE, VANILLYL NONYLAMIDE	Masaem Company	4dbeda13-b198-0cf0-e063-6294a90a8180	2026-03-24	Warnings	Exact identifier application number: M017
Barmicil Anti-itch	HYDROCORTISONE	OPMX LLC	850084c3-1dd4-eb8d-e053-2a91aa0a130b	2026-03-24	Warnings	Exact identifier application number: M017
Jeil Hangbang Paff Soo S Cataplasma	GLYCOL SALICYLATE, L-MENTHOL	Masaem Company	4dd040db-07cf-361a-e063-6394a90a8001	2026-03-24	Warnings	Exact identifier application number: M017
Zenol Double Action	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4da998fc-75a3-583f-e063-6394a90a59c7	2026-03-23	Warnings	Exact identifier application number: M017
Ultra Strength Topical Pain Relief Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD	4db9ae57-4ab4-8fe4-e063-6394a90a7e51	2026-03-23	Warnings	Exact identifier application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON	ALIVIO TOTAL ROLL ON	EVI LABS	4da01338-8739-08a8-e063-6294a90ae157	2026-03-22	Warnings	Exact identifier application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTAL	ALIVIO TOTAL	EVI LABS	4da1c3b8-9af2-6e9f-e063-6394a90a86ae	2026-03-22	Warnings	Exact identifier application number: M017
SORE NO MORE	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd	2026-03-20	Warnings	Exact identifier application number: M017
CVS Health Antiseptic Wound Wash	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	CVS Pharmacy	53ac017a-eccb-3b24-e054-00144ff88e88	2026-03-20	Warnings	Exact identifier application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%	ANTI ITCH GEL	Walgreens	3d6e8c62-2fcc-51c2-e063-6394a90a33f7	2026-03-20	Warnings	Exact identifier application number: M017
ANIXIKE Numbing	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5c52d7-8e81-b62f-e063-6394a90ad03e	2026-03-19	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d47e8c7-d293-bf63-e063-6294a90a5fd9	2026-03-18	Warnings	Exact identifier application number: M017
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	f7aa9330-c47c-4d2f-b784-11b831d919d6	2026-03-18	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	99726aa3-3b45-4175-8471-279419af5457	2026-03-18	Warnings	Exact identifier application number: M017
Dr.Harry COMFORT ZONE Cream	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4d32b89f-72e8-bc93-e063-6394a90a0bc8	2026-03-17	Warnings	Exact identifier application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain Relief	CAPSAICIN, MENTHOL	Milo Rod Import & Export, Inc.	c3622dc3-0c05-47c9-b70b-498946781906	2026-03-17	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