Biofreeze Precision Relief Pen

Product NDC: 59316-830
11-digit product format: 593160830
Labeler code: 59316
Product ID: 59316-830_51e07cc8-735b-2dce-e063-6394a90af835
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LIQUID
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-31
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 105 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 Precision Relief Pen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	105 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
2471404	Internal RxNorm lookup
2587602	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
b4cc1db5-a33f-17bc-e053-2995a90ab7eb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-830-37	Biofreeze Precision Relief Pen	34 mL in 1 BOTTLE	LIQUID	34	5
59316-830-38	Biofreeze Precision Relief Pen	1 in 1 CARTON	LIQUID	1	5
59316-830-38	Biofreeze Precision Relief Pen	34 mL in 1 BOTTLE	LIQUID	34	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-830-37	ML - Milliliter	59316-830	9e55e639-c3b5-4b51-8df2-1c8bf726bafd	1	2024-08-12
59316-830-38	ML - Milliliter	59316-830	e380948a-99a2-4e09-b438-300c4fc2cd44	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-830	BIOFREEZE PRECISION RELIEF PEN (MENTHOL) LIQUID [RB HEALTH (US) LLC]	4	Current NDC, Legacy NDC, 3 package rows	20241228_b4cc1db5-a33f-17bc-e053-2995a90ab7eb.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 105 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OKeeffes Working Hands Pain Relief Skin Protectant	ALLANTOIN, LIDOCAINE HYDROCHLORIDE	The Gorilla Glue Company/O'Keeffe's Company	0685da25-c9fa-e1cd-e063-6394a90ae1b3	2025-01-01	Warnings	Exact identifier application number: M017
Icy Hot with Lidocaine Pain Relieving	LIDOCAINE HCL AND MENTHOL	Chattem, Inc.	75b28b06-77ea-4fea-b516-2e8a0dac7037	2025-01-01	Warnings	Exact identifier application number: M017
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Fragrance-Free	HYDROCORTISONE	Lovely Skin, Inc.	c12af4c6-2f05-46ec-b901-1a4fcd750180	2024-12-31	Warnings	Exact identifier application number: M017
Pain Relieving Cream Lidocaine	BENZYL ALCOHOL, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	039a2036-54b2-cf28-e063-6294a90a8ce6	2024-12-31	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief Walgreens	MENTHOL 10.5%	WALGREEN COMPANY	f1daa68d-1b12-c28a-e053-2995a90a0949	2024-12-31	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Advanced Rx of Tennessee, LLC	0b7736df-c7e0-7d00-e063-6294a90aa57e	2024-12-31	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Advanced Rx Pharmacy of Tennessee, LLC	f4bfc4a6-06ef-1f76-e053-2995a90a2b8f	2024-12-31	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream	LIDOCAINE, MENTHOL	Sato Pharmaceutical Co., Ltd.	2251e96b-d050-4ec2-a6b9-6659610885bf	2024-12-30	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Safeway	af2e2ef3-0f3f-4592-8081-b6553ade2f5a	2024-12-26	Warnings	Exact identifier application number: M017
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier application number: M017
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier application number: M017
BiteMD External Analgesic First Aid Antiseptic	BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL	United Industries Corporation	4c60db03-6d2b-4ae0-a200-718b3a50eb0f	2024-12-23	Warnings	Exact identifier application number: M017
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier application number: M017
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier application number: M017
FOOT WORKS MAXIMUM CRACKED HEEL	BENZALKONIUM CHLORIDE, LIDOCAINE	COSMAX USA, CORPORATION	29f92230-d1d4-5e94-e063-6294a90af812	2024-12-23	Warnings	Exact identifier application number: M017
pain relief roll-on	LIDOCAINE 4%	Bionpharma Inc.	f607b6dc-8d13-604a-e053-2995a90a59ab	2024-12-23	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825	2024-12-23	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE 1%	Trifecta Pharmaceuticals USA LLC	af5daf6c-bcad-8ebf-e053-2a95a90af1b0	2024-12-20	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2587602	Biofreeze 10.5 % Topical Solution	PSN	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5
2471404	menthol 10.5 % Topical Solution	PSN	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5
2587602	menthol 105 MG/ML Topical Solution [Biofreeze]	SBD	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5
2471404	menthol 105 MG/ML Topical Solution	SCD	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5
2587602	Biofreeze 10.5 % Topical Solution	SY	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5
2587602	Biofreeze 105 MG/ML Topical Solution	SY	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5
2471404	menthol 10.5 % Topical Solution	SY	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-830-37	59316083037	34 mL in 1 BOTTLE (59316-830-37)	34 ml	2020-12-31	0000-00-00	No	No	Current
59316-830-38	59316083038	1 BOTTLE in 1 CARTON (59316-830-38) / 34 mL in 1 BOTTLE	1 bottle	2020-12-31	0000-00-00	No	No	Current