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 132 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF Gel-Tube	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bec1d4-2e18-4519-e053-2a95a90a1bbb	2024-04-29	Warnings	Exact identifier application number: M017
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Cream	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	16f26249-b508-2c6e-e063-6394a90a265b	2024-04-25	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	JHK Inc	5a4ac4cc-015a-48e7-81f8-93a895049afd	2024-04-25	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	ede15818-5d17-477d-a8be-7b36bb0770a6	2024-04-22	Warnings	Exact identifier application number: M017
Anti Itch	HYDROCORTISONE	Neilmed Pharmaceuticals Inc.	14b4f066-fde4-ac97-e063-6394a90ae64c	2024-04-20	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relief Patch	MENTHOL 5%	Walgreens Company	e33c90d1-2729-970f-e053-2995a90ad97a	2024-04-18	Warnings	Exact identifier application number: M017
HealthWise Cold Therapy Pain Relief Patch	MENTHOL	Veridian Healthcare	0ce356e0-90a3-ad52-e063-6294a90a404a	2024-04-18	Warnings	Exact identifier application number: M017
Walgreens Scalp Relief External analgesic	HYDROCORTISONE	Walgreen Company	da0a24c7-9295-4f22-b2c7-40000dad4b81	2024-04-18	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	164d4d62-00c0-e06d-e063-6294a90abd73	2024-04-17	Warnings	Exact identifier application number: M017
TIGER Balm PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	ca601b02-e9be-4d8d-a384-c62553302ceb	2024-04-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592a40a-a647-34bd-e063-6394a90a0a10	2024-04-08	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR, MENTHOL, METHYL SALICYLATE	PureTek Corporation	081837a8-9669-be1f-e063-6394a90a9d20	2024-04-05	Warnings	Exact identifier application number: M017
Pain Relieving Liniment	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	97a0c839-0927-4e54-aee2-ded2016ac4a0	2024-04-02	Warnings	Exact identifier application number: M017
HealthWise Capsaicin Heat Patch	CAPSAICIN	Veridian Healthcare	150c1f09-8aa7-67ea-e063-6294a90a950a	2024-04-01	Warnings	Exact identifier application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent	LIDOCAINE HCI	Veridian Healthcare	150d3e54-5c8d-19ef-e063-6394a90a70c2	2024-04-01	Warnings	Exact identifier application number: M017
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	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