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 94 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dollar General Cold-Hot Medicated Patches MENTHOL DOLGENCORP, LLC e13ab4d3-eb58-4874-925a-6a59df4dd29a 2025-04-14 Warnings Exact identifier application number: M017 AY BENDITO - PAIN RELIEF CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC b97f6b71-7de7-3217-e053-2a95a90aa426 2025-04-14 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0d85e-269d-0342-e053-2995a90ac63c 2025-04-14 Warnings Exact identifier application number: M017 Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 71a36691-9d9e-479d-bfdc-6f6b192ad2d0 2025-04-11 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited da3358ae-8679-6045-e053-2a95a90a50e3 2025-04-10 Warnings Exact identifier application number: M017 Jointflex JOINTFLEX Strides Consumer LLC b82ec69c-bd00-400b-bd94-ac15fb620f9b 2025-04-09 Warnings Exact identifier application number: M017 Zepol Topical Analgesic CAMPHOR, MENTHOL Laboratorios Zepol S.A. ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9 2025-04-09 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC cb5ca02b-0bc1-4b0b-b4b1-abef3222aa56 2025-04-09 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 32456887-aa09-8912-e063-6394a90a4ae7 2025-04-08 Warnings Exact identifier application number: M017 MUSCLE MENTHOL WATER-JEL TECHNOLOGIES 1af399af-07b0-4899-9bcc-1e244b63b1cf 2025-04-08 Warnings Exact identifier application number: M017 Lidocaine with Menthol LIDOCAINE HCL AND MENTHOL Kareway Product, Inc. 9ee46a5b-d00c-4254-e053-2995a90aeb3a 2025-04-08 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 324802c9-e2c2-bf74-e063-6394a90a8697 2025-04-08 Warnings Exact identifier application number: M017 OARS AND ALPS MUSCLE RECOVERY BALM MENTHOL, METHYL SALICYLATE Cosco International, Inc 8745802f-018d-4cf8-bbf3-3b04c8f54538 2025-04-08 Warnings Exact identifier application number: M017 NOVUM APR MENTHOL NOVUM SOLUTIONS INC 1b869a1f-5787-4d03-a546-43a8217b2b2c 2025-04-07 Warnings Exact identifier application number: M017 MAG 5 PT ROLL-ON PAIN RELIEF COOLING MENTHOL RENU LABORATORIES, LLC 31e4fa2c-3a98-d618-e063-6394a90aec1c 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC cc7cbf4a-8274-e463-e053-2995a90a51e0 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee018a-2c3c-3116-e053-2a95a90ac8d8 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee2b65-2759-0e62-e053-2a95a90a0378 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bdc7c7f3-ac98-8fe9-e053-2a95a90a2663 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bd4fdff1-9174-31c2-e053-2a95a90a749f 2025-04-07 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