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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONMENTHOL,PRAMOXINE HYDROCHLORIDERida LLCb62d09e4-7ced-49a9-8c83-3a8ef580f25a2026-06-23WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsExact identifier
application number: M017
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
application number: M017
Pain ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
application number: M017
Tiger Balm Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.011fc383-10bc-44cf-a67c-4be45fef33e02026-06-19WarningsExact identifier
application number: M017
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
application number: M017
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsExact identifier
application number: M017
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
application number: M017
SprayPain AwayCAPSAICINProximity Capital Partners LLC dba Asutrac603e999-2316-496a-e053-2995a90ab4ed2026-06-17WarningsExact identifier
application number: M017
SprayPain Away LavenderCAPSAICINProximity Capital Partners LLC dba Asutra547e2167-ade0-ac7e-e063-6294a90a18ea2026-06-17WarningsExact 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