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 125 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	070000d7-7d4d-439b-9a91-851ba7c027e6	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone anti itch	HYDROCORTISONE	H E B	a1a9fed8-4938-48b5-81f1-d3942d534bb8	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	ef9ea069-9b97-4bf5-aaac-deb85334dbd0	2024-10-03	Warnings	Exact identifier application number: M017
Basic Care Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	7fa13ab4-5f2d-4a48-816f-1b22d5f757b2	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	fb2beb08-0ad6-a89d-e053-6294a90aa6fe	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	da28097f-4b5c-6159-e053-2a95a90a7d96	2024-10-02	Warnings	Exact identifier application number: M017
Circatrix	CAPSAICIN	PureTek Corporation	cd3b1256-2df8-dc26-e053-2a95a90ad049	2024-10-02	Warnings	Exact identifier application number: M017
DermacinRx Penetral Cream	CAPSAICIN	PureTek Corporation	1e343a52-6071-3230-e054-00144ff8d46c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	36abfc2c-d424-4df8-968d-866342c96a56	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Balm	CAMPHOR MENTHOL	Eagle Indo Pharma, PT	87614869-9675-2c76-e053-2a95a90a48a9	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	d9a93daa-4e24-6690-e053-2a95a90a147c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Extra Strength	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	5e02fbe3-5bc7-430e-b661-3a760ddd8fe0	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	c62a4313-2c07-5f58-e053-2995a90a083a	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	e272ec90-3cd9-5b70-e053-2a95a90a1df4	2024-10-02	Warnings	Exact identifier application number: M017
RUGBY HYDROCORTISONE WITH ALOE	HYDROCORTISONE	A-S Medication Solutions	b2674075-aaa4-4c77-bcaa-a76336b3c321	2024-10-02	Warnings	Exact identifier application number: M017
Herb Street Anti-Itch Stick	HYDROCORTISONE	Balassa Laboratories Inc.	8717faae-59c3-4c6f-9ef1-285c0d2445ed	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Backache and Sore Muscle Relief	MENTHOL	Balassa Laboratories Inc.	aeac1b64-8689-4b3d-a41c-db41061257b5	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Arthritis Relief	MENTHOL/CAMPHOR	Balassa Laboratories Inc.	a9d8ceb7-def0-415f-8fc1-ff8dd3e41855	2024-10-01	Warnings	Exact identifier application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-Patch	LIDOCAINE	Galaxy Bio, Inc.	2243734a-4ea2-a5e5-e063-6294a90aba15	2024-10-01	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