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 107 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Calaspray Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	fda2afaf-3cd0-92b3-e053-6394a90a7493	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief Roll-On	LIDOCAINE HCL 4%, MENTHOL 1%	Derma Care Research Labs, LLC	ff32cbb2-79eb-9158-e053-6394a90ac357	2024-12-19	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE, 0.5%	Derma Care Research Labs	ffd7be08-0510-dfcb-e053-6394a90ad286	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Pain Relief Roll-On	CAPSAISIN 0.1%	Derma Care Research Labs, LLC	fda0d359-95eb-8b38-e053-6294a90a7b88	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relieving	MENTHOL 2%	Derma Care Research Labs, LLC	ff49ee63-6a87-c7a7-e053-6294a90a77a3	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relief Roll-On Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	dd80e560-6467-2166-e053-2995a90a88a8	2024-12-19	Warnings	Exact identifier application number: M017
DCH Labs Cool and Heat Roll-On	MENTHOL 16%	Derma Care Research Labs, LLC	d35d7720-44ce-3624-e053-2995a90a7fb4	2024-12-19	Warnings	Exact identifier application number: M017
Dr Goldsons Pain	MENTHOL 8%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	fb34b0d3-ccc0-305e-e053-6394a90a231d	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relieving	CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	dd06af3c-5452-9759-e053-2a95a90afc21	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Burn Relief Aloe Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	ec6efa4b-dcbe-1c2b-e053-2995a90ae043	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	ff31e515-5780-b77d-e053-6394a90af6b9	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE 4%	Derma Care Research Labs, LLC	00efda74-d434-04be-e063-6294a90a6d98	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Cold Therapy Pain Relief	MENTHOL 5%	Dolgencorp, LLC	ff3284d1-e73c-93bf-e053-6294a90aaf4e	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Pain Relieving Patch with Lidocaine	LIDOCAINE	DOLGENCORP, LLC	55828cd1-3a1e-48ac-bb01-4c50b96d09a2	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief	LIDOCAINE 4%, MENTHOL 1%	Derma Care Research Labs, LLC	00db480a-e510-a64d-e063-6394a90a4695	2024-12-19	Warnings	Exact identifier application number: M017
Pain, Burn, and Itch Relief	BENZOCAINE 20%, MENTHOL 0.5%	Derma Care Research Labs, LLC	fd9fe09f-3ae9-c5f5-e053-6394a90ad691	2024-12-19	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 4%	Derma Care Research Labs, LLC	00ed3175-c3ba-6545-e063-6394a90acfd1	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	00dd70f3-ecc3-33ba-e063-6294a90a4f32	2024-12-19	Warnings	Exact identifier application number: M017
Walgreens Kinesiology Pain Relief	LIDOCAINE, MENTHOL	Walgreen Co.	0fdbb310-8e65-4e0c-b413-a093964324a2	2024-12-19	Warnings	Exact identifier application number: M017
Signature Care Medicated Cold and Hot Patch	MENTHOL	Safeway	0335f1b3-5c8a-67b8-e063-6294a90a9847	2024-12-19	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