Home NDC 59316-111 PERFORM COOL and SOOTHING PAIN RELIEVING
Product NDC 59316-111
11-digit product format 593160111
Labeler code 59316
Product ID 59316-111_51e0a9b2-bf58-7444-e063-6394a90a3e3a
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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
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 59316-111-10 PERFORM COOL and SOOTHING PAIN RELIEVING 3 mL in 1 TUBE GEL 3 9 59316-111-11 PERFORM COOL and SOOTHING PAIN RELIEVING 30 mL in 1 BOTTLE GEL 30 9 59316-111-20 PERFORM COOL and SOOTHING PAIN RELIEVING 1 in 1 CARTON GEL 1 9 59316-111-20 PERFORM COOL and SOOTHING PAIN RELIEVING 118 mL in 1 TUBE GEL 118 9
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 (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 ARNICA MONTANA FLOWER INACTIVE INGREDIENT OZ0E5Y15PZ PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 HYPERICUM OIL INACTIVE INGREDIENT OZU2FC70HY PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 ILEX PARAGUARIENSIS LEAF INACTIVE INGREDIENT 1Q953B4O4F PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 LAVANDIN OIL INACTIVE INGREDIENT 9RES347CKG PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 LIME OIL INACTIVE INGREDIENT UZH29XGA8G PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 NUTMEG OIL INACTIVE INGREDIENT Z1CLM48948 PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 ORANGE OIL INACTIVE INGREDIENT AKN3KSD11B PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 PINE NEEDLE OIL (PINUS SYLVESTRIS) INACTIVE INGREDIENT 5EXL5H740Y PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 THYME OIL INACTIVE INGREDIENT 2UK410MY6B PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-111 PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [RB HEALTH (US) LLC] 8 Current NDC, Legacy NDC, 4 package rows 20241228_ef158f63-2d75-47a3-b94a-2d821d511863.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 89 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aloe Up SPF 50 Mineral ZINC OXIDE Aloe International, LLC 35bc3621-f4e4-42d3-e063-6394a90a7aad 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Kids Mineral ZINC OXIDE, TITANIUM DIOXIDE Aloe Care International, LLC 35cd16b0-bd81-8f68-e063-6294a90a3d8c 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Kids Mineral ZINC OXIDE Aloe International, LLC 35cd5542-947d-a042-e063-6394a90a13f8 2025-06-18 Warnings Exact identifier application number: M017 Relieve Your Pain MENTHOL Proximity Capital Partners LLC dba Asutra c12369dd-8305-edaf-e053-2995a90a0d3d 2025-06-18 Warnings Exact identifier application number: M017 Melt Pain Away CAPSAICIN Proximity Capital Partners LLC dba Asutra a95a11d7-a2ae-6654-e053-2a95a90a802c 2025-06-18 Warnings Exact identifier application number: M017 Recovery Roll-On MENTHOL, CAMPHOR PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA ebc9630f-6d8b-e4f0-e053-2995a90a0b49 2025-06-18 Warnings Exact identifier application number: M017 ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37cdfabc-1fdb-246a-e063-6394a90a008a 2025-06-17 Warnings Exact identifier application number: M017 ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37ce6c35-b211-43de-e063-6294a90ab773 2025-06-17 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE CREAM 1% Sun Pharmaceutical Industries, Inc. 312ddc8d-100e-cfac-e063-6294a90acd09 2025-06-16 Warnings Exact identifier application number: M017 Curist 5% Lidocaine LIDOCAINE 5% Little Pharma, Inc. f20241a2-c5b1-f124-e053-2995a90a891b 2025-06-16 Warnings Exact identifier application number: M017 Toast Screamin Menthol MENTHOL IDEAZ, LLC 37b48b1a-ef3d-afdc-e063-6294a90a6610 2025-06-16 Warnings Exact identifier application number: M017 Toast Freezin Cold MENTHOL, METHYL SALICYLATE IDEAZ, LLC 37b4d363-0099-8cd3-e063-6394a90a18d6 2025-06-16 Warnings Exact identifier application number: M017 Earths Care Anti-Itch CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM DLC Laboratories, Inc. ba65f58a-d590-498a-b8e7-a3d78935d880 2025-06-13 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc 5eb6574c-2066-4390-befc-8e5d2dd6ede2 2025-06-12 Warnings Exact identifier application number: M017 CHINESE RED TIGER LIDOCAINE PATCHES 4% LIDOCAINE, 1%MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36b9a7a2-5832-4ce5-e063-6294a90aed12 2025-06-12 Warnings Exact identifier application number: M017 PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 375bc794-3289-e610-e063-6294a90a4f9b 2025-06-12 Warnings Exact identifier application number: M017 Methyl Salicylate 10% Pain Relieving METHYL SALICYLATE PureTek Corporation 376493eb-5142-db6d-e063-6294a90a1e73 2025-06-12 Warnings Exact identifier application number: M017 Free and Pure Cold Therapy Pain Relief MENTHOL Walgreen Co. 22cbbffc-f876-411e-e063-6394a90a1b38 2025-06-12 Warnings Exact identifier application number: M017 Methylten 25% Pain Relieving METHYL SALICYLATE PureTek Corporation 3767b97e-ab0c-ac26-e063-6394a90a00cf 2025-06-12 Warnings Exact identifier application number: M017 SPF 50 Mineral Sunscreen ZINC OXIDE Inspec Solutions, LLC 36af9a0a-536b-ee1a-e063-6394a90aace4 2025-06-11 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 59316-111-10 59316011110 3 mL in 1 TUBE (59316-111-10) 3 ml 2015-05-18 2023-12-31 No No Current 59316-111-11 59316011111 30 mL in 1 BOTTLE (59316-111-11) 30 ml 2015-05-18 2023-12-31 No No Current 59316-111-20 59316011120 1 TUBE in 1 CARTON (59316-111-20) / 118 mL in 1 TUBE 1 tube 2015-05-18 0000-00-00 No No Current