Biofreeze Roll-On

Product NDC: 50090-6358
11-digit product format: 500906358
Labeler code: 50090
Product ID: 50090-6358_1e426c73-8145-47fe-9470-39c853f54446
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-17
Substance: MENTHOL
Active strength: 40 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 Roll-On
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	40 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
415974	Internal RxNorm lookup
1111683	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
814b37ea-5441-4cec-8794-71ca01d849ae	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6358-0	Biofreeze Roll-On	74 mL in 1 BOTTLE	GEL	74		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6358-0	ML - Milliliter	50090-6358	8768d2b3-9bd6-46d0-8426-3ac6ed8020de	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6358	BIOFREEZE ROLL-ON (MENTHOL) GEL [A-S MEDICATION SOLUTIONS]	3	Current NDC, 1 package rows	20231102_814b37ea-5441-4cec-8794-71ca01d849ae.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 37 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	498cd2aa-ee59-67b5-e063-6294a90ac242	2026-01-29	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	498d76d8-788b-4cc7-e063-6294a90a1696	2026-01-29	Warnings	Exact identifier application number: M017
MQUPIN Lidocaine Gel-Patch	LIDOCAINE GEL-PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	49703717-69a6-e480-e063-6394a90ac69c	2026-01-28	Warnings	Exact identifier application number: M017
MQXUNMI LIDOCAINE Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	49706db7-bacd-190f-e063-6394a90a3a8e	2026-01-28	Warnings	Exact identifier application number: M017
Joint and Muscle Relief Topical Analgesic	MENTHOL	Smart Cookie Solutions	1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d	2026-01-28	Warnings	Exact identifier application number: M017
VonaFlex Effective Pain Relief Topical Analgesic	LIDOCAINE HYDROCHLORIDE	OPTIMAL LABORATORIES, LLC	0901244a-7d41-413a-b424-92a807532f28	2026-01-28	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF	Dynarex	960e4240-cd09-2560-e053-2a95a90a7bcf	2026-01-28	Warnings	Exact identifier application number: M017
ALOE ICE SUNBURN RELIEF	LIDOCAINE HYDROCHLORIDE	Aloe Care International, LLC	56866fa8-052e-497c-a954-978d7d628949	2026-01-28	Warnings	Exact identifier application number: M017
Walgreens Original Strength Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Walgreen Company	a6a49dbb-74c7-47ca-88f2-3bb3d9acf914	2026-01-28	Warnings	Exact identifier application number: M017
Flobow QUIT SMOKING Nicotine	NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE	Jiangxi Yudexi Pharmaceutical Co., LTD	495b10ce-3d2d-1aa4-e063-6294a90a4f35	2026-01-27	Warnings	Exact identifier application number: M017
PAIN	REUSEABLE PAIN	Shenzhen Mengyue Technology Co., Ltd.	44e058fc-e1c0-742b-e063-6294a90ad225	2026-01-27	Warnings	Exact identifier application number: M017
HealthWise Pain Relieving Cream Lavender	MENTHOL	Veridian Healthcare	495eb6e9-69da-f7b6-e063-6294a90accee	2026-01-27	Warnings	Exact identifier application number: M017
HealthWise Pain Relieving Cream	MENTHOL	Veridian Healthcare	49548ab2-267e-1e2a-e063-6394a90ab391	2026-01-27	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores, Inc.	03feaaef-7401-d464-e063-6294a90a2b2d	2026-01-27	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	4a113699-1eb7-49b8-8cdf-2ad57db89b81	2026-01-27	Warnings	Exact identifier application number: M017
Healthy Back Institute Rub On Relief	ANALGESIC	Fullstack Fulfillment	284c29a3-5722-ce70-e063-6394a90a7fa0	2026-01-26	Warnings	Exact identifier application number: M017
Velocx for Joint and Muscle Pain Roll-On Applicator	MENTHOL, METHYL SALICYLATE	JMAD Consulting LLC, dba JMAD Labs	dbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d21	2026-01-26	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	CAPSAICIN	Meijer Distribution Inc	9b91658f-c15f-4222-bbd9-881b29de3b6e	2026-01-26	Warnings	Exact identifier application number: M017
TheraCare Muscle and Joint Gel Vanishing Scent	MENTHOL 2.5%	Veridian Healthcare	494d2a85-45a8-12a2-e063-6294a90a391b	2026-01-26	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief	LIDOCAINE	Trifecta Pharmaceuticals USA, LLC.	493c09d0-16d7-7413-e063-6394a90aa052	2026-01-26	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111683	BIOFREEZE 4 % Topical Gel	PSN	814b37ea-5441-4cec-8794-71ca01d849ae	3
415974	menthol 4 % Topical Gel	PSN	814b37ea-5441-4cec-8794-71ca01d849ae	3
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	814b37ea-5441-4cec-8794-71ca01d849ae	3
415974	menthol 0.04 MG/MG Topical Gel	SCD	814b37ea-5441-4cec-8794-71ca01d849ae	3
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	814b37ea-5441-4cec-8794-71ca01d849ae	3
1111683	Biofreeze 4 % Topical Gel	SY	814b37ea-5441-4cec-8794-71ca01d849ae	3
415974	menthol 4 % Topical Gel	SY	814b37ea-5441-4cec-8794-71ca01d849ae	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6358-0	50090635800	74 mL in 1 BOTTLE (50090-6358-0)	74 ml	2023-02-07	No	No	Current