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 50 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Absorbine Jr. Pain Relieving Knee Patch	ABSORBINE JR. PAIN RELIEVING KNEE PATCH	Clarion Brands, LLC	22f71254-e521-2d82-e063-6394a90a12d8	2025-12-28	Warnings	Exact identifier application number: M017
Absorbine Jr Back Patch	ABSORBINE JR BACK PATCH	Clarion Brands LLC.	22f5147e-ff2b-4ae8-e063-6394a90a4e54	2025-12-28	Warnings	Exact identifier application number: M017
Absorbine Jr. Pro Rollon	ABSORBINE JR. PRO ROLLON	Clarion Brands, LLC	470efcd0-d350-3dc4-e063-6394a90ab8c1	2025-12-28	Warnings	Exact identifier application number: M017
Med Rub Balm	ACHES AND PAIN BALM	Wellmetech Pharmaceutical Industries SDN BHD	a5801566-6bbe-44f6-8761-9c1ce3096900	2025-12-27	Warnings	Exact identifier application number: M017
N-Labs ArcticZen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	Nutriomo Labs PTE., LTD	46e92db7-a48b-2c7a-e063-6394a90a438e	2025-12-27	Warnings	Exact identifier application number: M017
Absorbine Jr. Plus	MENTHOL	Clarion Brands, LLC	46f4ad3c-7418-a6bf-e063-6394a90a4eb8	2025-12-27	Warnings	Exact identifier application number: M017
Equate Lidocaine Cool and Heat	LIDOCAINE 4% PLUS MENTHOL 1%	Walmart Stores Inc	b86769c3-a0b4-c481-e053-2a95a90af38b	2025-12-27	Warnings	Exact identifier application number: M017
Medicated Body Extra Strength Powder	MENTHOL 0.80%	Walmart Stores Inc	b0786418-7b28-d316-e053-2995a90a3ab5	2025-12-27	Warnings	Exact identifier application number: M017
Maximum Strength Medicated Foot Powder	MEDICATED FOOT POWDER	Walmart Stores Inc	b0794d48-eb8b-55c9-e053-2995a90a5b38	2025-12-27	Warnings	Exact identifier application number: M017
Walgreens 24-Hour Lidocaine Patch	LIDOCAINE 4%	Walgreens Company	b8402924-b5fc-0acd-e053-2a95a90a1805	2025-12-27	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Foot Pain Relief	MENTHOL	WISE CONSUMER PRODUCTS CO.	115f1abc-34aa-3c20-e063-6294a90a9764	2025-12-26	Warnings	Exact identifier application number: M017
Soothing Nerve Relief	MENTHOL	Wise Consumer Products	46e23c95-1a36-214e-e063-6394a90a98a8	2025-12-26	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Foot Pain Relief Combo Pack	MENTHOL	WISE CONSUMER PRODUCTS CO.	46e2c8b6-bd94-7100-e063-6294a90ac998	2025-12-26	Warnings	Exact identifier application number: M017
Pain Patch Perfecto 24 Hours Lidocaine 4 % Patch	LIDOCAINE	Painpatchperfecto LLC	a281c3e9-1c48-4905-98cc-3cedf6042adc	2025-12-25	Warnings	Exact identifier application number: M017
Aloe UP SPF 33 Mineral	ZINC OXIDE	Aloe Care International, LLC	35aa6196-682d-8f32-e063-6394a90aad99	2025-12-24	Warnings	Exact identifier application number: M017
ETADERM Numbing Cream	LIDOCAINE	NUEPHASE LLC	5292c6ff-b878-4e71-878b-4bf08207612e	2025-12-24	Warnings	Exact identifier application number: M017
Certain Dri Clinical Strength Prescription Protection Rollon	CERTAIN DRI CLINICAL STRENGTH PRESCRIPTION PROTECTION ROLLON	Clarion Brands LLC	46a1f92e-4411-3989-e063-6394a90a7038	2025-12-23	Warnings	Exact identifier application number: M017
PREMIERES PAIN	MENTHOL	Premiere Enterprises	128bd1e7-e961-416c-933b-fbd146e3d386	2025-12-23	Warnings	Exact identifier application number: M017
PREMIERES PAIN	MENTHOL	Premiere Enterprises	35ff19df-4cc4-4fce-bd30-d87d835e0e26	2025-12-23	Warnings	Exact identifier application number: M017
Premieres Pain	MENTHOL	Premiere Enterprises	1f081913-6106-4d06-a37a-631f710dbacb	2025-12-23	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