Biofreeze Overnight Gel

Product NDC: 59316-121
11-digit product format: 593160121
Labeler code: 59316
Product ID: 59316-121_51e06548-d75f-53d6-e063-6294a90a66eb
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: 2023-03-01
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 Gel
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
f5c8c08b-c7c0-f84d-e053-2a95a90add15	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59316-121-10	Biofreeze Overnight Gel	89 mL in 1 BOTTLE	GEL	89		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-121-10	ML - Milliliter	59316-121	7f28a9d8-6572-47d0-b64b-d01bd794e6cd	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-121	BIOFREEZE OVERNIGHT GEL (MENTHOL) GEL [RB HEALTH (US) LLC]	2	Current NDC, 1 package rows	20241228_f5c8c08b-c7c0-f84d-e053-2a95a90add15.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 58 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AleveX	CAMPHOR AND MENTHOL	Bayer HealthCare LLC	bc66bc1b-c0d5-2481-e053-2a95a90a75de	2025-12-04	Warnings	Exact identifier application number: M017
AleveX	CAMPHOR AND MENTHOL	Bayer HealthCare LLC	bafd199a-e198-d5d1-e053-2995a90ad1cb	2025-12-04	Warnings	Exact identifier application number: M017
AleveX	CAMPHOR AND MENTHOL	Bayer HealthCare LLC	bafdf06b-25f5-e29e-e053-2a95a90a5e1b	2025-12-04	Warnings	Exact identifier application number: M017
Milagroso	METHYL SALICYLATE	Pharmadel LLC	fdcc8f44-afa0-3af0-e053-6394a90aa46d	2025-12-04	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35221a-2fcb-2735-e063-6294a90a88ca	2025-12-04	Warnings	Exact identifier application number: M017
Pain Relieving	TROLAMINE SALICYLATE	CARDINAL HEALTH 110, LLC. DBA LEADER	b813262e-57c6-4d2c-8cc0-7a17f6f59343	2025-12-04	Warnings	Exact identifier application number: M017
Gold Bond Medicated Extra Strength Body	MENTHOL	Gold Bond Co LLC	7b75b7de-9c0b-4edf-b923-320f7d2bb1e6	2025-12-04	Warnings	Exact identifier application number: M017
Lidocaine Patch	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	38767081-7011-6602-e063-6394a90a2784	2025-12-03	Warnings	Exact identifier application number: M017
4% Lidocaine Maximum Strength Pain Relief	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	3e5a5165-a773-0501-e063-6294a90ae2f4	2025-12-03	Warnings	Exact identifier application number: M017
Leader Lidocaine	LIDOCAINE HCL	CARDINAL HEALTH	cece6765-0e2f-5ce9-e053-2995a90a3758	2025-12-03	Warnings	Exact identifier application number: M017
Westlake Lidocaine	LIDOCAINE HCL	Westlake Pharma LLC	0c586a14-1a2a-9f42-e063-6294a90a16c1	2025-12-03	Warnings	Exact identifier application number: M017
CVS Lidocaine Maximum Strength	LIDOCAINE HCL	CVS Pharmacy	87490c0f-a4d9-740e-e053-2a95a90a4724	2025-12-03	Warnings	Exact identifier application number: M017
CVS Maximum Strength Burn	LIDOCAINE HYDROCHLORIDE 4%	CVS Pharmacy	4510f379-c5a4-92c3-e063-6294a90a0a32	2025-12-03	Warnings	Exact identifier application number: M017
LidoPatch Pain Relief	LIDOCAINE, MENTHOL	JAR Laboratories	07289aa1-43ed-df31-e063-6394a90a764a	2025-12-03	Warnings	Exact identifier application number: M017
Equate Pain Relief Cream	4% LIDOCAINE HCL	Walmart, Inc	7d8e8a9a-5474-4c7b-e053-2991aa0a29f5	2025-12-03	Warnings	Exact identifier application number: M017
Solarcaine Burn Pain Relief 4oz	SOLARCAINE BURN PAIN RELIEF 4OZ	WellSpring Pharmaceutical Corporation	14f23c28-c713-4868-9f46-66363bf94b2c	2025-12-03	Warnings	Exact identifier application number: M017
ElixirCortiRelief	HYDROCORTISONE	ELIXIR HEALTHCARE USA, LLC.	a6ca66f3-9759-4c98-a758-45700bc08352	2025-12-02	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE 4%	Trifecta Pharmaceuticals USA, LLC.	12a27ce7-c547-7134-e063-6394a90a94bd	2025-12-02	Warnings	Exact identifier application number: M017
5Kind DMSO	MENTHOL, METHYL SALICYLATE	5KIND TRADING LTD	6a6c7241-f544-4784-9581-f5b172fdbec7	2025-12-02	Warnings	Exact identifier application number: M017
PEDIADERMICS ECZEMA 2	HYDROCORTISONE	RENU LABORATORIES, LLC	da840bf6-ed65-bafc-e053-2a95a90a92d5	2025-12-02	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	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3
415974	menthol 4 % Topical Gel	PSN	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3
415974	menthol 0.04 MG/MG Topical Gel	SCD	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3
1111683	Biofreeze 4 % Topical Gel	SY	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3
415974	menthol 4 % Topical Gel	SY	f5c8c08b-c7c0-f84d-e053-2a95a90add15	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59316-121-10	59316012110	89 mL in 1 BOTTLE (59316-121-10)	89 ml	2023-03-01	No	No	Current