PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON

Product NDC: 59316-112
11-digit product format: 593160112
Labeler code: 59316
Product ID: 59316-112_51e0a049-ce7a-fed7-e063-6294a90a0632
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: 2015-05-18
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 35 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: PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	35 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
808955	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
8af185ad-719e-4684-89c0-9c17c1277499	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59316-112-10	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON	89 mL in 1 BOTTLE	GEL	89		8
59316-112-10	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON	1 in 1 CARTON	GEL	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
HYPERICUM OIL	INACTIVE INGREDIENT	OZU2FC70HY	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
LAVANDIN OIL	INACTIVE INGREDIENT	9RES347CKG	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
LIME OIL	INACTIVE INGREDIENT	UZH29XGA8G	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
NUTMEG OIL	INACTIVE INGREDIENT	Z1CLM48948	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
PINE NEEDLE OIL (PINUS SYLVESTRIS)	INACTIVE INGREDIENT	5EXL5H740Y	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-112	PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241228_8af185ad-719e-4684-89c0-9c17c1277499.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 59 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POMG NIGHT TIME PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE	POMG LLC	28d7dfb0-a94c-90de-e063-6294a90a036a	2025-12-02	Warnings	Exact identifier application number: M017
Thermacare Max Strength Lidocaine	THERMACARE MAX STRENGTH LIDOCAINE	Clarion Brands LLC	44fed887-d1e0-d205-e063-6294a90ac416	2025-12-02	Warnings	Exact identifier application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ON	MENTHOL	SUNSET NOVELTIES, INC	45037bc1-aa03-11ae-e063-6294a90a6c96	2025-12-02	Warnings	Exact identifier application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ON	CAMPHOR	SUNSET NOVELTIES, INC	45048936-f3c9-25f7-e063-6394a90ac4a9	2025-12-02	Warnings	Exact identifier application number: M017
CAREALL Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM	New World Imports, Inc	3a01f57a-ebc6-4724-b625-1d1ea4b85e73	2025-12-01	Warnings	Exact identifier application number: M017
CareALL Arthritis and Muscle	CAPSAICIN	New World Imports, Inc	4867eac4-00ea-434e-b289-1c1ef0342c23	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	e2df8130-e7c8-4fde-a6d6-c71378991213	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	d04e473d-8bbc-475c-a0b1-ca5eed67fbc7	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Muscle Rub Ultra Strength	MENTHOL, METHYL SALICYLATE	New World Imports, Inc	cba7c084-379f-4a16-aeba-b11ca6e20d8a	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Muscle Rub Ultra Strength	MENTHOL, METHYL SALICYLATE	New World Imports, Inc	d066002d-8ceb-4d16-9744-d5ca25d2ad5a	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Musle and Joint	MENTHOL	New World Imports, Inc	013beea4-b2c2-4e84-b4cb-3125ac48e8c0	2025-12-01	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	A2A Integrated Pharmaceuticals, LLC	147f3594-7362-7a78-e063-6294a90a3e42	2025-11-30	Warnings	Exact identifier application number: M017
Aquanil HC	HYDROCORTISONE	Person and Covey	6b9258e4-c7c4-765e-e053-2991aa0a9f4e	2025-11-29	Warnings	Exact identifier application number: M017
Walgreen Pain Relieving Fragrance Free	LIDOCAINE HYDROCHLORIDE	WALGREENS CO.	62c50ded-3fc9-4f65-9bfb-1144ed2e36b4	2025-11-26	Warnings	Exact identifier application number: M017
Itch Relief	ITCH RELIEF GEL	Neilmed Pharmaceuticals Inc.	44811828-c32e-17fc-e063-6294a90add48	2025-11-26	Warnings	Exact identifier application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon	THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON	Clarion Brands LLC	4482d34d-eaca-5522-e063-6394a90a6afb	2025-11-26	Warnings	Exact identifier application number: M017
Sohm Pain Away	MENTHOL, CAMPHOR	SOHM, Inc	86632acf-80ae-48d7-a0bb-7ec980326bae	2025-11-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Pain Relief	LIDOCAINE 4%	Veridian Healthcare	6f2332c0-e078-40a8-9564-f47d21bc491b	2025-11-25	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON WARMING	CAMPHOR	Just Brands LLC	44779065-5f57-8f01-e063-6394a90a3f8e	2025-11-25	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON COOLING	MENTHOL	Just Brands LLC	44786cb6-176e-cc6e-e063-6394a90a54ad	2025-11-25	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
808955	menthol 3.5 % Topical Gel	PSN	8af185ad-719e-4684-89c0-9c17c1277499	8
808955	menthol 0.035 MG/MG Topical Gel	SCD	8af185ad-719e-4684-89c0-9c17c1277499	8
808955	menthol 3.5 % Topical Gel	SY	8af185ad-719e-4684-89c0-9c17c1277499	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-112-10	59316011210	1 BOTTLE in 1 CARTON (59316-112-10) / 89 mL in 1 BOTTLE	1 bottle	2015-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	8