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 76 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact identifier
application number: M017
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl ozMENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)BH GLOBAL HOLDINGS LLC1ddddbb6-2d01-c894-e063-6394a90acd582025-10-01WarningsExact identifier
application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%LIDOCAINEKenvue Brands LLC36a95afd-97e5-2271-e063-6394a90aea182025-09-30WarningsExact identifier
application number: M017
Capsaicin HeatCAPSAICINUniversal Distribution Center LLCb3b40f77-3b0b-4111-968b-f3a87a5701fa2025-09-29WarningsExact identifier
application number: M017
Caring Mills Menthol 4% Roll-OnMENTHOLVeridian Healthcaref4308c74-0860-4265-aeaf-a01301cca27a2025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED LARGEMENTHOLUniversal Distribution Center LLCd6780230-aa96-4055-b054-be41358568b62025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATEDMENTHOLUniversal Distribution Center LLCc19aa620-401d-43c4-804c-3611cc39e9f22025-09-29WarningsExact identifier
application number: M017
UniShield First Aid BurnLIDOCAINE HCLUnishieldf729c557-da4b-3fb5-e053-6394a90a41962025-09-28WarningsExact identifier
application number: M017
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
application number: M017
Zhuifeng Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3f12da60-26d1-4407-8e02-c3213ea3ad2a2025-09-26WarningsExact identifier
application number: M017
Gutong Tiegao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD5a5c3759-90e0-4a93-99cf-ddbf00aba10d2025-09-26WarningsExact identifier
application number: M017
Zhuanggu Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTDe3e98530-ce4d-47b9-9383-3088814034eb2025-09-26WarningsExact identifier
application number: M017
GUTONG TIEGAO PAIN RELIEVINGCAMPHOR AND MENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3adfac16-ea7b-47df-89f5-91bbd09c4fe12025-09-26WarningsExact identifier
application number: M017
Xpect Sting WipesBENZOCAINE 6%Cintas Corporationfeeae00d-e266-4ae4-90d2-524da38fa8132025-09-26WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Company0b4053a8-6c1c-621d-e063-6394a90a4f562025-09-25WarningsExact identifier
application number: M017
Unishield 1%HYDROCORTISONEUnishield4871a67f-fbb8-4a6b-ace4-d343490289082025-09-24WarningsExact 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