Biofreeze Overnight Roll-on

Product NDC: 59316-207
11-digit product format: 593160207
Labeler code: 59316
Product ID: 59316-207_51e06d5e-11fe-5814-e063-6294a90a2736
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-16
Substance: MENTHOL
Active strength: 40 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 Overnight Roll-on
Listing expiration: 2027-12-31

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
f67d7b7a-8922-73f6-e053-2995a90a2e80	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
59316-207-14	Biofreeze Roll-On and Overnight Roll-On	74 mL in 1 BOTTLE	GEL	74 mL	40 mg in 1mL	5
59316-207-14	Biofreeze Overnight 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
59316-207-14	ML - Milliliter	59316-207	984f94ed-b81d-4470-a2af-d26d054baea7	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-207	BIOFREEZE OVERNIGHT ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]	2	Current NDC, 1 package rows	20241228_f67d7b7a-8922-73f6-e053-2995a90a2e80.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 134 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	721658dc-3b1d-43ff-9032-e96851633cf9	2024-02-19	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief Roll on	MENTHOL	Troy Manufacturing, Inc.	978d5c2c-fdc4-4d25-83ec-0b9404ec8018	2024-02-19	Warnings	Exact identifier application number: M017
1168	1168 BURN SPRAY	Dynarex Corporation	1183a4f5-f875-dfb0-e063-6394a90af35f	2024-02-16	Warnings	Exact identifier application number: M017
Pain Relief	BENZOCAINE	Safetec of America, Inc.	de84e598-d047-4fae-b2ed-155a3788bc6f	2024-02-16	Warnings	Exact identifier application number: M017
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	ab9bf09d-bc8c-6d17-e053-2995a90a6c36	2024-02-14	Warnings	Exact identifier application number: M017
Natures Oil 16% Menthol	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	2fbe23b7-23a3-4f0b-bc08-0205256f5d68	2024-02-14	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Rugby Laboratories	4c11876c-57ec-4429-a8c4-fb95baa4074a	2024-02-13	Warnings	Exact identifier application number: M017
Itch stopping Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	11368823-d4af-a536-e063-6294a90a7a2e	2024-02-12	Warnings	Exact identifier application number: M017
Walgreens Boil Pain Relief	BOIL PAIN RELIEF	Walgreens Company	d11bd769-68d0-4057-bc2a-72719f16011e	2024-02-12	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Rugby Laboratories	c5915c84-84a2-46f6-9f97-0d9873e9944a	2024-02-12	Warnings	Exact identifier application number: M017
Leader Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	952e56ea-5cbc-4078-bd01-5d3b6864a5ce	2024-02-09	Warnings	Exact identifier application number: M017
Leader Ultra Strength Muscle Rub Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	9d99a900-60e0-454c-98e0-2c63eb910cf1	2024-02-09	Warnings	Exact identifier application number: M017
Pain Relieving	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	28821ffa-a138-47b5-8857-beadf7a20d43	2024-02-08	Warnings	Exact identifier application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic Rub	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	fd0ea70a-ef12-48b1-8d9d-cc5f6417f854	2024-02-08	Warnings	Exact identifier application number: M017
Pain Relieving Cooling	MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	3574d48a-b546-4ea7-b470-071bb328de64	2024-02-08	Warnings	Exact identifier application number: M017
Advil Targeted Relief	CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE	Haleon US Holdings LLC	16e6be21-7b43-443a-89ec-3bdf0ec0dfc1	2024-02-08	Warnings	Exact identifier application number: M017
POINT RELIEF COLD SPOT Pain Relieving	MENTHOL	FABRICATION ENTERPRISES	96f1d592-6cec-412e-a5fd-cf3c4f68644f	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	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
1111683	BIOFREEZE 4 % Topical Gel	PSN	f67d7b7a-8922-73f6-e053-2995a90a2e80	3
415974	menthol 4 % Topical Gel	PSN	f67d7b7a-8922-73f6-e053-2995a90a2e80	3
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	f67d7b7a-8922-73f6-e053-2995a90a2e80	3
415974	menthol 0.04 MG/MG Topical Gel	SCD	f67d7b7a-8922-73f6-e053-2995a90a2e80	3
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	f67d7b7a-8922-73f6-e053-2995a90a2e80	3
1111683	Biofreeze 4 % Topical Gel	SY	f67d7b7a-8922-73f6-e053-2995a90a2e80	3
415974	menthol 4 % Topical Gel	SY	f67d7b7a-8922-73f6-e053-2995a90a2e80	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59316-207-14	59316020714	74 mL in 1 BOTTLE (59316-207-14)	74 ml	2023-03-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BioFreeze Day & Overnight Roll-On	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	5
BiOFREEZE ® Overnight Roll-on	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	3