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 49 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAIN RELIEF PATCHES LIDOCAINE Harris Teeter 5a0501e8-bc06-4e33-8db8-93b21a715141 2025-12-29 Warnings Exact identifier application number: M017 Hot and Cold Medicated Patch MENTHOL Harris Teeter 9debd4ef-c21b-41ae-afd1-58f47c51c99c 2025-12-29 Warnings Exact identifier application number: M017 Maximum OTC Strength Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) 0e9a711c-ddf4-af63-e063-6294a90a0ebe 2025-12-29 Warnings Exact identifier application number: M017 Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Harris Teeter 3f5b4eee-49c4-408c-9af2-e7924c26ac63 2025-12-29 Warnings Exact identifier application number: M017 talc-free medicated body MENTHOL Davion, Inc 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b 2025-12-29 Warnings Exact identifier application number: M017 H-E-B Medicated Corn Starch Foot Powder MENTHOL Davion, Inc a6675e00-bc6b-4466-a283-4cece5f91970 2025-12-29 Warnings Exact identifier application number: M017 Maximum Strength Medicated Foot Powder MENTHOL Davion, Inc 7b442d99-ac19-4f65-828d-954c5350ef5a 2025-12-29 Warnings Exact identifier application number: M017 HEB Medicated Cornstarch Body Powder MENTHOL Davion, Inc df1331fb-48df-4f21-8564-0468078fd12d 2025-12-29 Warnings Exact identifier application number: M017 Honest Med Capsaicin Patch CAPSAICIN Proper Buys LLC 30169d44-b1b2-5c0f-e063-6294a90ae159 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Lavender Roll-on LIDOCAINE HCL Proper Buys LLC 2dcd40a9-3fdd-a71e-e063-6294a90a704f 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Pain Relief Patch LIDOCAINE Proper Buys LLC 13a5243f-7116-e4da-e063-6394a90aa543 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Pain-Relieving Patch MENTHOL, METHYL SALICYLATE, CAMPHOR CVS Pharmacy, Inc. 1f90899c-eeca-2362-e063-6294a90aa0da 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Cooling Patch MENTHOL CVS Pharmacy, Inc 1f90cefe-bcce-5e17-e063-6294a90a5736 2025-12-28 Warnings Exact identifier application number: M017 Point Relief LidoSpot with Menthol LIDOCAINE, MENTHOL Fabrication Enterprises f0c69693-bfea-4006-9620-63b222d25d38 2025-12-28 Warnings Exact identifier application number: M017 DISCOUNT DRUG MART PAIN RELIEF PATCHES LIDOCAINE Discount Drug Mart, Inc e36e7d0a-d554-4601-b535-b41ee84a6b24 2025-12-28 Warnings Exact identifier application number: M017 Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Discount Drug Mart, Inc c01e1a14-bfbc-4c52-8a67-b77acf2d8853 2025-12-28 Warnings Exact identifier application number: M017 TopCare Pain Relief Patch LIDOCAINE, MENTHOL Topco Associates LLC d4c89c4f-d69a-7786-e053-2995a90a71e7 2025-12-28 Warnings Exact identifier application number: M017 Kroger Lidocaine Pain Relieving LIDOCAINE HCL Kroger Company 12d94ba6-56ac-3816-e063-6394a90a44c6 2025-12-28 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Ahold U.S.A., Inc, 7e7a813e-424d-4a78-9c72-541c3c62606a 2025-12-28 Warnings Exact identifier application number: M017 Amazon Basics Cold and Hot Medicated Patch MENTHOL Amazon.com Services LLC e3b4db12-c846-b984-e053-2a95a90a8e9a 2025-12-28 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