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 47 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 4a24e813-6dbc-3fd1-e063-6294a90a4ff0 2026-01-01 Warnings Exact identifier application number: M017 Lidozen Patch LIDOCAINE, MENTHOL Village Pharma LLC d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6 2026-01-01 Warnings Exact identifier application number: M017 FEMININE PAIN RELIEF MENTHOL, UNSPECIFIED FORM BeYou Together Ltd 9636b973-fe7e-481e-a6e9-8070347c0883 2025-12-31 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL FSA Store Inc. 47434af6-0fdd-9615-e063-6394a90ab9e8 2025-12-31 Warnings Exact identifier application number: M017 Winco Lidocaine Pain Patch 4% 5ct LIDOCAINE PAIN PATCH 4% WINCO FOODS, LLC 47439162-fc34-f0d0-e063-6394a90a29ab 2025-12-31 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH QUEST USA CORP. 1ad47834-4f8e-c692-e063-6294a90a7e77 2025-12-31 Warnings Exact identifier application number: M017 Dermagesic PRAMOXINE HCL, ZINC OXIDE, CALAMINE Llorens Pharmaceutical International Division bbff6b53-29da-45c1-8ccd-3e9df7f250e0 2025-12-31 Warnings Exact identifier application number: M017 Dologesic Roll-On LIDOCAINE HCL Llorens Pharmaceutical International Division, Inc. 81546810-85a8-45fe-b9e6-cdd02cc4c080 2025-12-31 Warnings Exact identifier application number: M017 Mentholatum Soothing Vapor Rub Lavender CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 47473b24-a3e3-2858-e063-6394a90a5920 2025-12-31 Warnings Exact identifier application number: M017 Eucerin Itch Relief Intensive Calming MENTHOL Beiersdorf Inc a7a78af1-1f5a-684d-e053-2a95a90a6ae9 2025-12-31 Warnings Exact identifier application number: M017 Eucerin Skin Calming Itch Relief Treatment MENTHOL Beiersdorf Inc 7e568311-1e6b-9b4b-e053-2991aa0a7b67 2025-12-31 Warnings Exact identifier application number: M017 Steady Freddy LIDOCAINE Medical Symbiosis Pty Ltd caa9eae9-7028-5185-e053-2a95a90ac504 2025-12-31 Warnings Exact identifier application number: M017 HYDROCORTISONE ANTI-ITCH CREAM Water-Jel Technologies 3d34ae31-265a-46bc-a52d-546ea5bb24b6 2025-12-31 Warnings Exact identifier application number: M017 Antibacterial Lidocaine Wound Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Water-Jel Technologies, LLC ef1a6100-7f78-1fdb-e053-2a95a90abf20 2025-12-31 Warnings Exact identifier application number: M017 Kroger Pain Relief Lidocaine Patch LIDOCAINE Kroger Company f6407554-c9a7-24e2-e053-2a95a90aae02 2025-12-30 Warnings Exact identifier application number: M017 Kroger Hot and Cold Medicated Patch MENTHOL Kroger Company 0331c1dd-fe30-421a-85a7-6c6886e7ab27 2025-12-30 Warnings Exact identifier application number: M017 Menthol, Camphor MENTHOL, CAMPHOR Chemco Corporation 472fb097-92e5-c230-e063-6294a90ab33a 2025-12-30 Warnings Exact identifier application number: M017 MENTHOL MENTHOL CHEMCO CORPORATIOM 472fb99c-dcc2-d9a9-e063-6294a90a794c 2025-12-30 Warnings Exact identifier application number: M017 Nufabrx Elbow Sleeve CAPSAICIN Nufabrx LLC 473004cd-f7f9-3c68-e063-6294a90a5b8a 2025-12-30 Warnings Exact identifier application number: M017 Nufabrx Leg Sleeve CAPSAICIN Nufabrx LLC 473015ed-3e0f-6eae-e063-6294a90a4c74 2025-12-30 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