Home NDC 59316-112 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.
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 Uploaded 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 113 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VAGISIL Anti-Itch Medicated Wipes Maximum Strength PRAMOXINE HYDROCHLORIDE Combe Incorporated b848f53d-8aea-4efe-aa2c-009d5121fc33 2024-12-12 Warnings Exact identifier application number: M017 Walgreens Cool and Heat MENTHOL 16% Walgreens ce1585f4-ca65-8d0c-e053-2995a90a8e89 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Cool n Heat LIDOCAINE 4% Walgreens ce1b21d6-7aa6-2b18-e053-2995a90a4c91 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Pain Burn Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Walgreens cc6e4b42-fdd8-6ff7-e053-2995a90a3d1d 2024-12-11 Warnings Exact identifier application number: M017 Pramoxine Itch relief PRAMOXINE HCL 1% CVS e947694c-c122-0291-e053-2995a90ac39a 2024-12-11 Warnings Exact identifier application number: M017 Arthritis Cream TROLAMINE SALICYLATE 10% CVS d1663f50-479b-4d55-e053-2995a90a223f 2024-12-11 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS d1660d55-1ee0-7aa2-e053-2995a90a6579 2024-12-11 Warnings Exact identifier application number: M017 CVS Muscle Rub MENTHOL 10%, METHYL SALICYLATE 15% CVS Health c72c9a95-4226-6d69-e053-2a95a90a8e1c 2024-12-11 Warnings Exact identifier application number: M017 BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Kenvue Brands LLC 0a41ec65-bd0b-4fc6-807d-74f353341cc7 2024-12-11 Warnings Exact identifier application number: M017 Serum X LIDOCAINE HYDROCHLORIDE AO Biologix, LLC e07b6268-6400-6849-e053-2a95a90a8b3e 2024-12-11 Warnings Exact identifier application number: M017 PlusCBD Pain Cream (Penetrating) 2oz CAMPHOR, MENTHOL CV Sciences, Inc. ca39d327-6bf3-3408-e053-2a95a90af2d5 2024-12-11 Warnings Exact identifier application number: M017 Blistex Medicated DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL Blistex Inc. e95439d3-f12b-4c1c-999a-79f2ddba4cfb 2024-12-11 Warnings Exact identifier application number: M017 Blistex Foille Medicated First Aid BENZOCAINE AND CHLOROXYLENOL Blistex Inc. e2eca808-e97b-43e0-aa51-7025cc61c7a8 2024-12-11 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE J&A Digital Inc. ff95a536-35b3-4006-b43c-cce359e86aa9 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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