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 71 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Cold and Hot MENTHOL, AND METHYL SALICYLATE Safeway Inc. ab201023-e3dc-52ec-e053-2995a90a1f18 2025-10-24 Warnings Exact identifier application number: M017 HealthWise Medicated Cold Hot 5% Patch MENTHOL Veridian Healthcare 15aef56f-cd25-05ac-e063-6394a90a07bb 2025-10-23 Warnings Exact identifier application number: M017 Alivio LIDOCAINE Amerise Pharmaceuticals LLC eb3a98f1-c875-4f08-8b4b-44e22626b609 2025-10-23 Warnings Exact identifier application number: M017 Pain Relieveing Gel-Patch LIDOCAINE Bullet point LLC 41d507c4-ad37-2686-e063-6394a90aae5b 2025-10-23 Warnings Exact identifier application number: M017 ActivICE MENTHOL Medline Industries, LP 98fa9a34-0e1e-0997-e053-2a95a90ac77d 2025-10-23 Warnings Exact identifier application number: M017 Coralite Pain Relief Hot MENTHOL AND CAPSAICIN United Exchange Corporation 78eb133d-01bb-6466-e053-2991aa0accc0 2025-10-23 Warnings Exact identifier application number: M017 Americaine BENZOCAINE Insight Pharmaceuticals LLC 4fd14452-0285-40c4-b835-36935c2056b2 2025-10-23 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bc1c0c-63d5-0d41-e063-6394a90a341b 2025-10-22 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bd0769-6ba0-d0d5-e063-6294a90af7c9 2025-10-22 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Knee MENTHOL United Exchange Corp. aa5873bd-af64-41cc-8f16-7714c56bca96 2025-10-22 Warnings Exact identifier application number: M017 Family Care Muscle Rub CAMPHOR, MENTHOL, AND METHYL SALICYLATE United Exchange Corp. 63006bb5-76e8-eb64-e053-2991aa0a95ad 2025-10-22 Warnings Exact identifier application number: M017 Winco Cold and Hot Medicated Patch Large MENTHOL WINCO FOODS, LLC af0d86c4-f74e-2dbe-e053-2a95a90a74c1 2025-10-22 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 064a6149-a0e2-8a73-e063-6394a90a7953 2025-10-22 Warnings Exact identifier application number: M017 Topical Analgesic MENTHOL Youngevity International Inc. b4693947-f5b3-6fd3-e053-2995a90ab581 2025-10-22 Warnings Exact identifier application number: M017 PAIN RELIEVING LIDOCAINE Medhome Pharma Inc 41cb1135-84e0-0c9a-e063-6294a90ada96 2025-10-22 Warnings Exact identifier application number: M017 KINKAN AMMONIA, CAMPHOR (NATURAL), MENTHOL KINKANDO CO., LTD . f2c0f3e1-792b-4798-bf6d-acd1bbefa261 2025-10-21 Warnings Exact identifier application number: M017 Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 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