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
IngredientStrength
MENTHOL, UNSPECIFIED FORM35 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808955Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8af185ad-719e-4684-89c0-9c17c1277499Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-112-10PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON89 mL in 1 BOTTLEGEL898
59316-112-10PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON1 in 1 CARTONGEL18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3APERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3APERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
HYPERICUM OILINACTIVE INGREDIENTOZU2FC70HYPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
LAVANDIN OILINACTIVE INGREDIENT9RES347CKGPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
LIME OILINACTIVE INGREDIENTUZH29XGA8GPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
NUTMEG OILINACTIVE INGREDIENTZ1CLM48948PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740YPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
THYME OILINACTIVE INGREDIENT2UK410MY6BPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-112PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC]7Current NDC, Legacy NDC, 2 package rows20241228_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 40 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
application number: M017
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsExact identifier
application number: M017
Pain Relieving PatchLIDOCAINEFlexiGo Inc.4868af2a-c4be-9c68-e063-6394a90a565b2026-01-15WarningsExact identifier
application number: M017
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
application number: M017
Careland Lidocaine 4 Pain Relieving Gel-PatchesLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6ca8382-7ce5-4df9-912e-8a0ac04231162026-01-15WarningsExact identifier
application number: M017
Neuropathy CreamMENTHOL CREAMOwell Naturals Brand, LLC48739205-627b-41d0-e063-6394a90a34622026-01-15WarningsExact identifier
application number: M017
BLT 1BENZOCAINECENTURA PHARMACEUTICALS INC3eea2171-850b-4045-e054-00144ff8d46c2026-01-15WarningsExact identifier
application number: M017
Icy Hot Lidocaine DryLIDOCAINE, MENTHOLChattem, Inc.d500a74e-ab93-4919-8665-a89e9d4cad282026-01-15WarningsExact identifier
application number: M017
Cortizone 10 Bug Bite Relief1% HYDROCORTISONEChattem, Inc.b21b6c04-8246-4567-98cf-64e8c588e79c2026-01-15WarningsExact identifier
application number: M017
Gold Bond Intensive Relief Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLChattem, Inc.e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f82026-01-14WarningsExact identifier
application number: M017
Cortizone-10 Soothing Aloe CremeHYDROCORTISONEChattem, Inc.1a841bf0-9d7b-4566-b442-aa9bcc8278462026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Sensitive Skin CremeHYDROCORTISONEChattem, Inc.b139917c-00bb-4cb3-995d-a6d2f2c295c62026-01-14WarningsExact identifier
application number: M017
Cortizone 10 for PsoriasisHYDROCORTIZONEChattem, Inc.fad9eedb-95e1-4e1a-91e5-0bfd077e0cf52026-01-14WarningsExact identifier
application number: M017
Pain Relief Roll OnTOPICAL ANALGESICEagle Labs Inc2380a400-062a-4a8d-a594-a2e0972190442026-01-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINE 4%AvKARE70aace2f-47b4-e961-e053-2991aa0a63672026-01-14WarningsExact identifier
application number: M017
JUST CBD - ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLC485f355a-4458-67b6-e063-6394a90ab2a02026-01-14WarningsExact identifier
application number: M017
Relief Pain Relieving CreamMENTHOLCorganics, LP85814fff-35f8-447f-b669-87eaf55e98592026-01-14WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub CherryCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company486269c9-af3a-7856-e063-6294a90a378c2026-01-14WarningsExact identifier
application number: M017
Mentholatum Vapor MaxCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company4863606f-f7c8-b4a4-e063-6294a90a11382026-01-14WarningsExact identifier
application number: M017
Hydrocortisone Cream Intensive HealingHYDROCORTISONE CREAMWalgreens8a3f486c-1353-466d-9ea7-c14559b53bf32026-01-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808955menthol 3.5 % Topical GelPSN8af185ad-719e-4684-89c0-9c17c12774998
808955menthol 0.035 MG/MG Topical GelSCD8af185ad-719e-4684-89c0-9c17c12774998
808955menthol 3.5 % Topical GelSY8af185ad-719e-4684-89c0-9c17c12774998

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-112-10593160112101 BOTTLE in 1 CARTON (59316-112-10) / 89 mL in 1 BOTTLE1 bottle2015-05-180000-00-00NoNoCurrent