Biofreeze Professional

Product NDC: 59316-115
11-digit product format: 593160115
Labeler code: 59316
Product ID: 59316-115_51e07a73-db68-3e69-e063-6394a90a6bdb
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
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

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
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
6bef9ccb-7a5a-4c67-b1bc-a92b167312da	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-115-11	Biofreeze Professional	3 mL in 1 PACKET	GEL	3	12
59316-115-20	Biofreeze Professional	118 mL in 1 TUBE	GEL	118	12
59316-115-30	Biofreeze Professional	473 mL in 1 BOTTLE	GEL	473	12
59316-115-40	Biofreeze Professional	946 mL in 1 BOTTLE	GEL	946	12
59316-115-50	Biofreeze Professional	3785 mL in 1 BOTTLE	GEL	3785	12
59316-115-82	Biofreeze Professional	100 in 1 CARTON	GEL	100	12
59316-115-82	Biofreeze Professional	3 mL in 1 PACKET	GEL	3	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-115-20	ML - Milliliter	59316-115	6bb636bf-c424-483f-a96c-25d573e887e1	1	2022-03-09
59316-115-30	ML - Milliliter	59316-115	b8900c01-67f9-4986-9516-3b93c0a9f904	1	2022-01-06
59316-115-40	ML - Milliliter	59316-115	49c29547-36c8-4df3-a918-7ccd9b78214f	1	2022-09-12
59316-115-50	ML - Milliliter	59316-115	693a9dea-91e4-4573-9a86-f6c0b4ff1380	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-115	BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC]	11	Current NDC, Legacy NDC, 7 package rows	20231114_6bef9ccb-7a5a-4c67-b1bc-a92b167312da.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 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	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	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	12
415975	menthol 5 % Topical Gel	PSN	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	12
1794892	menthol 0.05 MG/MG Topical Gel [Biofreeze]	SBD	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	12
415975	menthol 0.05 MG/MG Topical Gel	SCD	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	12
1794892	Biofreeze 5 % Topical Gel	SY	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	12
415975	menthol 5 % Topical Gel	SY	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	12
1794892	BIOFREEZE 5 % Topical Gel	PSN	66ff9726-20da-688a-e053-2a91aa0a59ac	6
415975	menthol 5 % Topical Gel	PSN	66ff9726-20da-688a-e053-2a91aa0a59ac	6
1794892	menthol 0.05 MG/MG Topical Gel [Biofreeze]	SBD	66ff9726-20da-688a-e053-2a91aa0a59ac	6
415975	menthol 0.05 MG/MG Topical Gel	SCD	66ff9726-20da-688a-e053-2a91aa0a59ac	6
1794892	Biofreeze 5 % Topical Gel	SY	66ff9726-20da-688a-e053-2a91aa0a59ac	6
415975	menthol 5 % Topical Gel	SY	66ff9726-20da-688a-e053-2a91aa0a59ac	6
1794892	BIOFREEZE 5 % Topical Gel	PSN	cbeac814-59d8-4c13-8e73-bca66f797f8d	3
415975	menthol 5 % Topical Gel	PSN	cbeac814-59d8-4c13-8e73-bca66f797f8d	3
1794892	menthol 0.05 MG/MG Topical Gel [Biofreeze]	SBD	cbeac814-59d8-4c13-8e73-bca66f797f8d	3
415975	menthol 0.05 MG/MG Topical Gel	SCD	cbeac814-59d8-4c13-8e73-bca66f797f8d	3
1794892	Biofreeze 5 % Topical Gel	SY	cbeac814-59d8-4c13-8e73-bca66f797f8d	3
415975	menthol 5 % Topical Gel	SY	cbeac814-59d8-4c13-8e73-bca66f797f8d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-115-11	59316011511	3 mL in 1 PACKET (59316-115-11)	3 ml	2016-06-03	0000-00-00	No	No	Current
59316-115-20	59316011520	118 mL in 1 TUBE (59316-115-20)	118 ml	2016-06-03	0000-00-00	No	No	Current
59316-115-30	59316011530	473 mL in 1 BOTTLE (59316-115-30)	473 ml	2016-06-03	0000-00-00	No	No	Current
59316-115-40	59316011540	946 mL in 1 BOTTLE (59316-115-40)	946 ml	2016-06-03	0000-00-00	No	No	Current
59316-115-50	59316011550	3785 mL in 1 BOTTLE (59316-115-50)	3785 ml	2016-06-03	0000-00-00	No	No	Current
59316-115-82	59316011582	100 PACKET in 1 CARTON (59316-115-82) / 3 mL in 1 PACKET	100 packet	2019-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biofreeze Professional Gel	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	12
Biofreeze Professional Gel	A-S Medication Solutions	2025-01-09	HUMAN OTC DRUG LABEL	3
Biofreeze Professional Gel	NuCare Pharmaceuticals,Inc.	2024-06-06	HUMAN OTC DRUG LABEL	6
Biofreeze Professional Gel	NuCare Pharmaceuticals,Inc.	2018-10-05	HUMAN OTC DRUG LABEL	1