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 99 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tylenol Precise Nighttime Pain Relieving	CAMPHOR, MENTHOL	Kenvue Brands LLC	2ef4fe16-0820-6aad-e063-6294a90a8449	2025-02-25	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Preferred Pharmaceuticals Inc.	c259ef92-5d07-4590-adf1-3a106333eee0	2025-02-21	Warnings	Exact identifier application number: M017
Cortizone 10 Ultra Soothing Itch Relief	HYDROCORTISONE	Chattem, Inc.	8a9e2d32-a65f-4253-8041-4146f4e3b738	2025-02-21	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll On	MENTHOL	ADP Health Limited	420d8cdc-f47f-4d33-bf25-9033ff266c49	2025-02-19	Warnings	Exact identifier application number: M017
AVCOO Pain Relief	MENTHOL	ADP Health Limited	700ce2cf-749e-40be-91c3-850d9b2168ca	2025-02-19	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	Jell Pharmaceuticals Pvt. Ltd	2e7c49de-5438-4858-e063-6294a90ad98c	2025-02-19	Warnings	Exact identifier application number: M017
VTROUY Tattoo Numbing Cream	TATTOO NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2e899851-b3cd-0758-e063-6294a90afea8	2025-02-19	Warnings	Exact identifier application number: M017
Pomada Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE	Genomma Lab USA	9d98f48b-6d88-4df9-9459-7cf7ba5de044	2025-02-19	Warnings	Exact identifier application number: M017
Pain Relieving Cream	HISTAMINE DIHYDROCHLORIDE	Mediapower, Inc. DBA Dr Newton's And Naturals	9eeea033-ae87-4d83-85d0-b8fa653a0806	2025-02-19	Warnings	Exact identifier application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular	ALUMINUM CHLOROHYDRATE	Sodalis USA, LLC	7839cf53-dbd2-4dbb-a309-1581d51f8adc	2025-02-18	Warnings	Exact identifier application number: M017
CANNA NUMB Roll On	LIDOCAINE HYDROCHLORIDE, MENTHOL	Cannanumb LLC	c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4	2025-02-17	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz.	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	7173b141-123e-6cd4-e053-2a95a90a8600	2025-02-12	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz. 3 pk	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	71c186a1-8283-2482-e053-2995a90acc1f	2025-02-12	Warnings	Exact identifier application number: M017
Roman Swipes	BENZOCAINE	Roman Health Ventures Inc.	7f0eac8c-7235-99d8-e053-2a91aa0a634e	2025-02-12	Warnings	Exact identifier application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR	EVI LABS	EVI LABS	2df7658d-83d3-41ac-e063-6294a90ab1dd	2025-02-12	Warnings	Exact identifier application number: M017
Signature Care Medicated Pain Relief Patch	LIDOCAINE	Safeway, Inc.	2165a342-5f8b-78e0-e063-6394a90a06c4	2025-02-12	Warnings	Exact identifier application number: M017
CheeZheng Pain Relieveing Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd.	abcebdf1-9037-4094-93e1-ce8f20b18ea7	2025-02-11	Warnings	Exact identifier application number: M017
Tibetree Pain Relieveing Medicated Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	4216bd48-5c62-4e87-adcc-67bf7152d64d	2025-02-11	Warnings	Exact identifier application number: M017
AsperFlex	LIDOCAINE	Akron Pharma Inc.	ab50525e-b534-452b-8c25-2992c0cbf862	2025-02-10	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Olakino Therapeutics LLC	2a41a621-c6f7-5819-e063-6394a90ae67d	2025-02-07	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	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