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 100 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliveing Patch	LIDOCAINE 4%	simple diagnostics	02ed0b27-bba9-ec0c-e063-6294a90a014d	2025-02-07	Warnings	Exact identifier application number: M017
FlexDermal Pain Relieving Roll-On	MENTHOL	SOLVADERM LLC	d4d8050e-0761-4491-8635-39c806701eb5	2025-02-06	Warnings	Exact identifier application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine	LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE	Clarion Brands LLC	2d7e9f6a-0f21-b103-e063-6294a90a912f	2025-02-06	Warnings	Exact identifier application number: M017
signature care Hydrocortisone	HYDROCORTISONE	Safeway	9fe16fc5-77e3-47f5-a943-85bc6565c0d4	2025-02-06	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	2d685602-5cd6-3b36-e063-6394a90a3c5d	2025-02-05	Warnings	Exact identifier application number: M017
Lidocore	LIDOCAINE	iON Pharma, LLC	204c3e50-1ac8-f442-e063-6294a90ae7b5	2025-02-05	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream Extreme	MENTHOL 16%, CAMPHOR 11%	Telebrands Corp	2d54077e-4c8d-aaae-e063-6394a90adb41	2025-02-04	Warnings	Exact identifier application number: M017
Capsaicin External Analgesic	CAPSAICIN	NuCare Pharmaceuticals,Inc.	fd90a67d-d60d-a849-e053-6394a90a2cc8	2025-02-04	Warnings	Exact identifier application number: M017
Rugby Muscle Rub Cream	MUSCLE RUB CREAM	NuCare Pharmaceuticals, Inc.	2d58c15a-5ddb-1b16-e063-6294a90a3fbb	2025-02-04	Warnings	Exact identifier application number: M017
Cetilar	MENTHOL 1.4%	PharmaNutra Usa Corp.	2dd14bd4-b4e1-bc7d-e063-6394a90a1e59	2025-02-04	Warnings	Exact identifier application number: M017
Stopain Extra Strength Continuous	MENTHOL	Troy Manufacturing, Inc.	0d199d39-5b47-4c7f-b83a-757f39aa17b6	2025-02-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	2d42192b-8889-a896-e063-6294a90a4fc8	2025-02-03	Warnings	Exact identifier application number: M017
Tiger Balm Pain Relieving Muscle	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	96b06d3f-8685-4314-ad7d-5d2720f4dde6	2025-02-03	Warnings	Exact identifier application number: M017
Icy Hot Medicated No Mess Applicator	MENTHOL	Chattem, Inc.	4ce2b823-7ef5-4cca-a2d8-2fe781bc958e	2025-02-01	Warnings	Exact identifier application number: M017
Cortizone 10 Intensive Healing Itch Relief Cream	HYDROCORTISONE	Chattem, Inc.	cdbeb825-3152-4f74-9fd1-93bccfc0e31a	2025-02-01	Warnings	Exact identifier application number: M017
Cortizone 10 Soothing Aloe Itch Relief	HYDROCORTISONE	Chattem, Inc.	1962abb3-6ca7-4934-9efe-20287b1c2a5b	2025-02-01	Warnings	Exact identifier application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol	MENTHOL	Inspec Solutions LLC	d4276749-eeff-28f7-e053-2a95a90a593d	2025-01-31	Warnings	Exact identifier application number: M017
MyDerm Bite Relief	BENZOCAINE	Inspec Solutions LLC.	88615668-16b5-7840-e053-2a95a90a9208	2025-01-31	Warnings	Exact identifier application number: M017
Maximum Strength Blue Emu Pain Relief Blu Emu	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	5e02b820-e53a-42cb-abdb-2925617c29ca	2025-01-31	Warnings	Exact identifier application number: M017
Sunset Novelties Herquake	NUMBING LUBRICANT	SUNSET INTIMATES GROUP INC	2ceeca3e-9197-9166-e063-6394a90ae908	2025-01-30	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