Home NDC 58980-615 ARCTIC RELIEF
Product NDC 58980-615
11-digit product format 589800615
Labeler code 58980
Product ID 58980-615_db73c60c-1ff8-4b16-a467-6f0b8727f1d6
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form GEL
Route TOPICAL
Labeler STRATUS PHARMACEUTICALS INC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-09-15
Substance MENTHOL, UNSPECIFIED FORM
Active strength 3.969 g/113.4g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 ARCTIC RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 3.969 g/113.4g
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 58980-615-40 ARCTIC RELIEF 113.4 g in 1 TUBE GEL 113.4 6 58980-615-40 ARCTIC RELIEF 1 in 1 BOX GEL 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Camphor (Synthetic) ACTIVE INGREDIENT 5TJD82A1ET ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 Menthol ACTIVE INGREDIENT L7T10EIP3A ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 Camphor (Synthetic) ACTIVE MOIETY 5TJD82A1ET ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 Menthol ACTIVE MOIETY L7T10EIP3A ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 carbomer homopolymer type c INACTIVE INGREDIENT 4Q93RCW27E ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 FD&C blue NO. 1 INACTIVE INGREDIENT H3R47K3TBD ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 FD&C yellow NO. 5 INACTIVE INGREDIENT I753WB2F1M ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 ilex paraguariensis leaf INACTIVE INGREDIENT 1Q953B4O4F ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1 water INACTIVE INGREDIENT 059QF0KO0R ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-615 ARCTIC RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [STRATUS PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 2 package rows 20241102_d27fbc17-46b7-4d52-ba29-c99b6c63144a.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 91 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 PLANTAR FASCIITIS Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 37570149-dae1-a4f2-e063-6294a90a3245 2025-06-11 Warnings Exact identifier application number: M017 Diabecin CS Cream MENTHOL, CAPSAICIN Puretek Corporation 33ef2233-7a66-ee65-e063-6294a90ac55a 2025-06-10 Warnings Exact identifier application number: M017 KINKAN COOL DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL KINKANDO CO., LTD . 82011efe-825c-4102-b6f1-59eff4c8040a 2025-06-10 Warnings Exact identifier application number: M017 MQUPIN Knee Patch KNEE PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 37438a70-dab7-ecb5-e063-6394a90afefb 2025-06-10 Warnings Exact identifier application number: M017 ORTHOGEL Menthol 3.5% Roll On MENTHOL LiquidCapsule Manufacturing LLC 99424327-67e9-43b5-a117-94c9643413c1 2025-06-07 Warnings Exact identifier application number: M017 Lightning Pain Relief MENTHOL Ebanel Laboratories, Inc 36edbc3f-501c-c1ea-e063-6394a90af6af 2025-06-06 Warnings Exact identifier application number: M017 FREEZE IT Menthol Roll On MENTHOL LiquidCapsule Manufacturing LLC 33094afe-db9d-4b92-8047-6dd611484fc9 2025-06-05 Warnings Exact identifier application number: M017 Band Aid Antiseptic Cleansing BENZALKONIUM CHLORIDE, PRAMOXINE HCL Kenvue Brands LLC d55e6b09-0587-61a9-e053-2995a90afaf5 2025-06-05 Warnings Exact identifier application number: M017 FREEZE IT Menthol MENTHOL LiquidCapsule Manufacturing LLC de8d8007-5718-4fb4-a8c6-4650d2ca9c8f 2025-06-05 Warnings Exact identifier application number: M017 HEEL PAIN Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36bacb5f-c1af-2e97-e063-6394a90afe5c 2025-06-04 Warnings Exact identifier application number: M017 Capsaicin 0.075% Cream CAPSAICIN ViolaCare, Inc. 30911225-a6d7-4b2b-9005-b733373e2877 2025-06-04 Warnings Exact identifier application number: M017 LidoGuard LIDOCAINE HCL ViolaCare, Inc. 531383aa-4f0f-4fe0-91f4-d809b39f160f 2025-06-04 Warnings Exact identifier application number: M017 HealthWise Lidocaine and Menthol LIDOCAINE AND MENTHOL Veridian Healthcare 36c27642-f913-1aad-e063-6294a90a4343 2025-06-04 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 58980-615-40 58980061540 1 TUBE in 1 BOX (58980-615-40) / 113.4 g in 1 TUBE 1 tube 2017-09-15 0000-00-00 No No Current