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 57 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AY BENDITO HEMP ROLL-ON	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	3e552afc-9305-8825-e063-6294a90a1afe	2025-12-08	Warnings	Exact identifier application number: M017
AY BENDITO HEMP	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	457d89aa-4a84-94a6-e063-6294a90a20c0	2025-12-08	Warnings	Exact identifier application number: M017
Gold Bond Medicated Anti-Itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Gold Bond Co LLC	4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b	2025-12-05	Warnings	Exact identifier application number: M017
Orajel for Cold Sores Double Medicated, Cream	BENZOCAINE AND WHITE PETROLATUM	Church & Dwight Co., Inc.	b8699a40-8464-ca02-e053-2995a90a4260	2025-12-05	Warnings	Exact identifier application number: M017
Thompson Hydrocortisone 1%	HYDROCORTISONE	Thompson	f8740314-7e1f-815e-e053-6294a90a6eae	2025-12-05	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING UNSCENTED	LIDOCAINE HCL	Just Brands LLC	453f44e2-9e5b-8695-e063-6394a90a4389	2025-12-05	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON COOLING	MENTHOL	Just Brands LLC	453fa1a7-368c-ae50-e063-6294a90a5507	2025-12-05	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON WARMING	CAMPHOR	Just Brands LLC	4540221f-cf9f-9b6a-e063-6294a90adec3	2025-12-05	Warnings	Exact identifier application number: M017
Gold Bond Extra Strength	MENTHOL	Gold Bond Co LLC	3e84375f-95d3-420c-b222-02a757412592	2025-12-04	Warnings	Exact identifier application number: M017
Gold Bond Medicated Pain and Itch Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	d240e9b8-3506-42ab-8a50-05e8d3fac4ff	2025-12-04	Warnings	Exact identifier application number: M017
BLT Skin Cream	BENZOCAINE, LIDOCAINE, TETRACAINE	M2B Pharma LLC	9dc5db9d-9e0a-cd28-e053-2995a90a6bf7	2025-12-04	Warnings	Exact identifier application number: M017
AleveX	CAMPHOR AND MENTHOL	Bayer HealthCare LLC	bc66bc1b-c0d5-2481-e053-2a95a90a75de	2025-12-04	Warnings	Exact identifier application number: M017
AleveX	CAMPHOR AND MENTHOL	Bayer HealthCare LLC	bafd199a-e198-d5d1-e053-2995a90ad1cb	2025-12-04	Warnings	Exact identifier application number: M017
AleveX	CAMPHOR AND MENTHOL	Bayer HealthCare LLC	bafdf06b-25f5-e29e-e053-2a95a90a5e1b	2025-12-04	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35221a-2fcb-2735-e063-6294a90a88ca	2025-12-04	Warnings	Exact identifier application number: M017
Pain Relieving	TROLAMINE SALICYLATE	CARDINAL HEALTH 110, LLC. DBA LEADER	b813262e-57c6-4d2c-8cc0-7a17f6f59343	2025-12-04	Warnings	Exact identifier application number: M017
Gold Bond Medicated Extra Strength Body	MENTHOL	Gold Bond Co LLC	7b75b7de-9c0b-4edf-b923-320f7d2bb1e6	2025-12-04	Warnings	Exact identifier application number: M017
Lidocaine Patch	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	38767081-7011-6602-e063-6394a90a2784	2025-12-03	Warnings	Exact identifier application number: M017
4% Lidocaine Maximum Strength Pain Relief	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	3e5a5165-a773-0501-e063-6294a90ae2f4	2025-12-03	Warnings	Exact identifier application number: M017
Leader Lidocaine	LIDOCAINE HCL	CARDINAL HEALTH	cece6765-0e2f-5ce9-e053-2995a90a3758	2025-12-03	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