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		2026-10-27

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 52 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HERSTAT GST Genital Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e8d27684-fb15-2e6a-e053-2a95a90a248f	2025-12-19	Warnings	Exact identifier application number: M017
Kroger Anti Itch	HYDROCORTISONE	The Kroger Co	46547277-f11a-b9e7-e063-6294a90a2ccd	2025-12-19	Warnings	Exact identifier application number: M017
Kroger Cool and Heat Roll-On	MENTHOL	Kroger	46551d07-3006-c3ec-e063-6294a90aa3f2	2025-12-19	Warnings	Exact identifier application number: M017
Naughty Kitty Kat	NO GAG DEEP THROAT SPRAY	INKED SUGAR, INC	170eb644-c72c-5744-e063-6394a90a767d	2025-12-19	Warnings	Exact identifier application number: M017
Tiger Balm Red Extra Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	ce703715-4c11-472c-9270-daac87b7be05	2025-12-19	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Foot Pain Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	da82cc0e-cc39-408e-87e1-c35bb6f9f51e	2025-12-19	Warnings	Exact identifier application number: M017
Health Trak Plus Menthol-Infused Pain Relief Socks	MENTHOL	Railroad Sock LLC	43413e55-1db2-fc1a-e063-6394a90a7167	2025-12-18	Warnings	Exact identifier application number: M017
BIO-ICE	MENTHOL, CAMPHOR	Electrostim Medical Services Inc. d/b/a EMSI	1bfd1468-9139-43b1-9709-d47b63d17cfb	2025-12-18	Warnings	Exact identifier application number: M017
Lidotrode	LIDOCAINE	Strand Health Group	1fd20b9a-b8bc-c94f-e063-6394a90a2b69	2025-12-18	Warnings	Exact identifier application number: M017
A Health Itch Relief Gel	ITCH RELIEF GEL	Bionpharma, Inc.	ecf5decb-c98b-7739-e053-2995a90a5541	2025-12-18	Warnings	Exact identifier application number: M017
After Burn	2.5% LIDOCAINE HCL	Tender Corporation d/b/a Adventure Ready Brands	4640395f-a76c-d022-e063-6294a90adde6	2025-12-18	Warnings	Exact identifier application number: M017
SPARTAN WIPES	ENDURANCE WIPES	TIV PRIME SRL	26d02431-2c95-001c-e063-6394a90a29c7	2025-12-18	Warnings	Exact identifier application number: M017
Stopain Extra Strength Continuous	MENTHOL	Troy Manufacturing, Inc.	a0f76968-d22c-4b1c-a9e6-8d0179a2e98e	2025-12-18	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE	LIDOCAINE HYDROCHLORIDE AND MENTHOL,	KOBAYASHI Healthcare International, Inc.	e364ff83-4aaf-4897-a7da-06581bc321f2	2025-12-18	Warnings	Exact identifier application number: M017
Tiger Balm White Regular Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	f406161e-a9c4-47d1-8b21-93b1b7938063	2025-12-17	Warnings	Exact identifier application number: M017
Resinol	PETROLATUM AND RESORCINOL	ResiCal, Inc.	03f57a4a-f94b-4ba6-b709-41cfb6e16261	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Maximum Pain Relief	LIDOCAINE	Veridian Healthcare	afc3c16d-0076-44b2-ae7e-5f36d4d8088e	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Max Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	f39a27da-6799-4fc6-97ca-101eac4a9360	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Original Menthol	MENTHOL	Veridian Healthcare	e4bfb6b0-545e-4fbc-8538-4f41a6be1025	2025-12-17	Warnings	Exact identifier application number: M017
Welly Polka First Aid Kit	HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Dongguan Shenglian Tins Products Co., Ltd.	d7c4314c-c4c6-4adf-b384-3ac7a7108319	2025-12-17	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