Biofreeze Colorless Roll-On

Product NDC: 59316-206
11-digit product format: 593160206
Labeler code: 59316
Product ID: 59316-206_51b58e7e-a6c1-b40f-e063-6394a90a1f1e
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: 2013-01-17
Substance: MENTHOL, UNSPECIFIED FORM
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 Colorless Roll-On
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	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
a8d59d45-0e85-43d1-affd-bbe922c4acb1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59316-206-10	Biofreeze Colorless Roll-On	1 in 1 CARTON	GEL	1		10
59316-206-10	Biofreeze Colorless Roll-On	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59316-206-10	ML - Milliliter	59316-206	7d320a39-8167-4221-b750-d09fba2f8683	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-206	BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241228_a8d59d45-0e85-43d1-affd-bbe922c4acb1.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 11 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	56b8d0cc-2f35-7d38-e063-6294a90ad06d	2026-07-16	Warnings	Exact identifier application number: M017
ANTIPHLAMINE	L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE	Masaem Company	56b93c89-295b-f33a-e063-6294a90a5fe4	2026-07-16	Warnings	Exact identifier application number: M017
Meriwether Skin Pain Relief	MENTHOL, UNSPECIFIED FORM	Meriwether Skin LLC	f6e155be-5879-4176-bb0e-e364f2e5cdf9	2026-07-16	Warnings	Exact identifier application number: M017
Medi-First Muscle Rub Cream	MENTHOL, METHYL SALICYLATE	Unifirst First Aid Corporation	56a6b8b2-7ab0-9854-e063-6294a90ab5ba	2026-07-15	Warnings	Exact identifier application number: M017
Painsil Pain Relief Roll-On	LIDOCAINE HYDROCHLORIDE	Painsil LLC	dee39dff-5749-4ef2-a9ed-182f25e01f67	2026-07-14	Warnings	Exact identifier application number: M017
VARICOSE VEINS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL & LLC	5692914f-1b14-e3e3-e063-6394a90a94bf	2026-07-14	Warnings	Exact identifier application number: M017
ZyloRelief	LIDOCAINE HYDROCHLORIDE	Highmark Pharma LLC	635f5b98-f74c-495f-a537-686fcba9ccad	2026-07-14	Warnings	Exact identifier application number: M017
ENOKON PAIN RELIEF Spray.	PAIN RELIEF SPRAY.	Henan Enokon Medical Instrument Co., Ltd.	5675ec21-b947-2206-e063-6294a90aa509	2026-07-12	Warnings	Exact identifier application number: M017
Topcare Pain Relief Patch	PAIN RELIEF PATCH MEDICATED 5% MENTHOL	76162	4f00d0b8-d2f4-843b-e063-6294a90a332b	2026-07-12	Warnings	Exact identifier application number: M017
Penetral Roll-on	CAPSAICIN 0.025%	PureTek Corporation	56204c03-8b15-a8b5-e063-6394a90a8189	2026-07-10	Warnings	Exact identifier application number: M017
Intensive Healing Itch Relief	ITCH RELIEF CREAM	NeilMed Pharmaceuticals Inc	563ef1d5-2180-bc45-e063-6294a90a813d	2026-07-10	Warnings	Exact identifier application number: M017
AVON Foot Works Arthritis Achy Foot and Muscle	METHYL SALICYLATE	COSMAX USA, CORPORATION	56440d3f-bc93-cebb-e063-6294a90a5f79	2026-07-10	Warnings	Exact identifier application number: M017
CHEONG KUN PAIN RELIEVING	CAMPHOR	CHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED	557d5cb3-2a05-4f45-e063-6394a90a9b12	2026-07-10	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL	Reckitt Benckiser LLC	485c8208-c93b-5b84-e063-6394a90ab77a	2026-07-10	Warnings	Exact identifier application number: M017
Fit Mist Pain Relief	MENTHOL	Aroma Sensations Inc	f5a98544-8bd7-42dc-a594-5559e3920e29	2026-07-09	Warnings	Exact identifier application number: M017
Nuturna Sciatica	MENTHOL	Micelle Laboratories, Incorporated	ff200864-bedf-4138-bdec-2b23701406dd	2026-07-09	Warnings	Exact identifier application number: M017
Lidocaine cream	DRS LIDOCAINE 5% CREAM	OL PHARMA TECH LLC. (Drs. Pharmacy)	372fe018-1e5a-9ec4-e063-6294a90a1500	2026-07-09	Warnings	Exact identifier application number: M017
Nupharmisto 4% Lidocaine Numbing cream	LIDOCAINE 4%	EveryMarket Inc	5615e49d-e03b-f915-e063-6294a90a1786	2026-07-08	Warnings	Exact identifier application number: M017
CAREALL Musle and Joint	MENTHOL	New World Imports, Inc	561cc103-ae88-8f30-e063-6294a90a05c4	2026-07-08	Warnings	Exact identifier application number: M017
HealthWise Medicated Cold Hot	MENTHOL	Veridian Healthcare, LLC	561e1409-d1d8-e35d-e063-6394a90a4d8f	2026-07-08	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
1111683	BIOFREEZE 4 % Topical Gel	PSN	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
415974	menthol 4 % Topical Gel	PSN	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
1111683	menthol 0.04 MG/MG Topical Gel [Biofreeze]	SBD	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
415974	menthol 0.04 MG/MG Topical Gel	SCD	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
1111683	Biofreeze 0.04 MG/MG Topical Gel	SY	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
1111683	Biofreeze 4 % Topical Gel	SY	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10
415974	menthol 4 % Topical Gel	SY	a8d59d45-0e85-43d1-affd-bbe922c4acb1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-206-10	59316020610	1 BOTTLE, WITH APPLICATOR in 1 CARTON (59316-206-10) / 89 mL in 1 BOTTLE, WITH APPLICATOR	2013-01-17	0000-00-00	No	No	Current