Biofreeze Roll-On and Overnight Roll-On

Product NDC: 59316-209
11-digit product format: 593160209
Labeler code: 59316
Product ID: 59316-209_51e076b8-984a-b24a-e063-6294a90ae9c0
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: KIT
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-01
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 Roll-On and Overnight Roll-On
Listing expiration: 2027-12-31

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
4d3dcb8f-2075-6bbc-e063-6394a90a4992	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	Strength	SPL version
59316-205-14	Biofreeze Roll-On and Overnight Roll-On	74 mL in 1 BOTTLE	GEL	74 mL	40 mg in 1mL	5
59316-207-14	Biofreeze Roll-On and Overnight Roll-On	74 mL in 1 BOTTLE	GEL	74 mL	40 mg in 1mL	5
59316-209-14	Biofreeze Roll-On and Overnight Roll-On	1 in 1 BOTTLE	KIT	1		5
59316-209-14	Biofreeze Roll-On and Overnight Roll-On	2 in 1 KIT	KIT	2		5

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 95 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAG 5 PT ROLL-ON PAIN RELIEF COOLING	MENTHOL	RENU LABORATORIES, LLC	31e4fa2c-3a98-d618-e063-6394a90aec1c	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	cc7cbf4a-8274-e463-e053-2995a90a51e0	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee018a-2c3c-3116-e053-2a95a90ac8d8	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee2b65-2759-0e62-e053-2a95a90a0378	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bdc7c7f3-ac98-8fe9-e053-2a95a90a2663	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bd4fdff1-9174-31c2-e053-2a95a90a749f	2025-04-07	Warnings	Exact identifier application number: M017
GREEN GUARD Topical Pain Relief	LIDOCAINE HCI	Ultra Distributors Inc	b6f0041c-47fc-0bcd-e053-2a95a90ab1f9	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebc1c6-93fb-efd6-e053-2995a90a25bb	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 4	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0e9ac7c-a840-2e05-e053-2a95a90a33f1	2025-04-07	Warnings	Exact identifier application number: M017
CBDMEDIC Active Sport Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec5f47-2f8e-0558-e053-2a95a90aa7ca	2025-04-07	Warnings	Exact identifier application number: M017
Hot Cold Medicated Patches	HOT COLD MEDICATED PATCHES	Henan Enokon Medical Instrument Co., Ltd.	159266a8-94fa-e2ff-e063-6394a90a9a77	2025-04-02	Warnings	Exact identifier application number: M017
Pain Relief Patch	PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592d29d-e275-a44d-e063-6294a90ab17d	2025-04-02	Warnings	Exact identifier application number: M017
Jointflex	CAMPHOR	Strides Consumer LLC	766b73f2-67bd-4d5c-805c-1057b3981ebf	2025-04-02	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Asclemed USA, Inc.	d4d556c1-b64b-4b8e-8e4b-4f40eda24250	2025-04-01	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	31ce185e-07b7-d837-e063-6394a90a1fb0	2025-04-01	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL 10.5%	CVS	d0ea80ce-38b2-acde-e053-2995a90a47e5	2025-03-31	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	A2A Integrated Pharmaceuticals, LLC	31431866-6fb5-2acd-e063-6294a90ac520	2025-03-31	Warnings	Exact identifier application number: M017
Citrus Cleansing Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	f136616d-9f32-4e55-a495-b7466fd68526	2025-03-28	Warnings	Exact identifier application number: M017
Zpol ULTRA	MENTHOL, METHYL SALICYLATE	Laboratorios Zepol S.A.	1a1433a6-8d04-96df-e063-6394a90a987b	2025-03-27	Warnings	Exact identifier application number: M017
Muscle Recovery Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	1c347267-b653-41bf-9967-7feff17c38af	2025-03-27	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	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
415974	menthol 4 % Topical Gel	PSN	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
415974	menthol 0.04 MG/MG Topical Gel	SCD	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
1111683	Biofreeze 4 % Topical Gel	SY	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5
415974	menthol 4 % Topical Gel	SY	4d3dcb8f-2075-6bbc-e063-6394a90a4992	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59316-205-14	59316020514	74 mL in 1 BOTTLE	74 ml				Historical
59316-207-14	59316020714	74 mL in 1 BOTTLE	74 ml				Historical
59316-209-14	59316020914	2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14)	2 bottle	2026-04-01	No	No	Current