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 12 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Natures Willow Balm Roll On Pain Relief MENTHOL WB Ventures LLC 3b1834e6-75cd-5380-e063-6294a90ad1d5 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm Itch Relief Cream MENTHOL WB Ventures LLC 0ce31b5d-4401-460c-e063-6394a90ab558 2026-07-08 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 560a4abf-31dd-333f-e063-6294a90a3505 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm MENTHOL WB VENTURES LLC b9f50c43-b0d5-39a8-e053-2995a90a04f1 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Bug Bite Balm MENTHOL WB Ventures LLC b9fab18f-32c7-d5bd-e053-2995a90a6d0f 2026-07-08 Warnings Exact identifier application number: M017 Salonpas pain relieving hot CAPSAICIN, MENTHOL Hisamitsu Pharmaceutical Co., Inc. d2aa8820-a947-404b-b617-e692fbd16502 2026-07-07 Warnings Exact identifier application number: M017 Quali Yi Tiao Gen Pain Patch CAPSAICIN PATCH Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory 33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d 2026-07-07 Warnings Exact identifier application number: M017 MUYOHON Numbing Cream NUMBING CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 55caf0a5-f062-a6c3-e063-6294a90ae073 2026-07-04 Warnings Exact identifier application number: M017 Targeted Warming Capsaicin Patch CAPSAICIN Army & Air Force Exchange Service 55b539f8-38c4-594e-e063-6394a90afbaa 2026-07-03 Warnings Exact identifier application number: M017 TopCare Health Pain Relief LIDOCAINE HYDROCHLORIDE Topco Associates LLC 485b0671-da09-19d7-e063-6294a90aca5d 2026-07-03 Warnings Exact identifier application number: M017 Mineral Ice Methol Pain Relief MENTHOL 10.5 % Sunflora Inc 6ddd9e97-f717-4d5a-9658-26449a3cc831 2026-07-02 Warnings Exact identifier application number: M017 Burn Relief LIDOCAINE AmerisourceBergen Drug Corporation 7d898e33-ded7-c9b9-e053-2a91aa0adf7c 2026-07-01 Warnings Exact identifier application number: M017 Desert Harvest Releveum with Lidocaine LIDOCAINE HYDROCHLORIDE Desert Harvest, Inc 9ad514ab-a6bd-4564-8ba3-0149032ebf36 2026-07-01 Warnings Exact identifier application number: M017 CVS No Mess Cortisone HYDROCORTISONE Natural Essentials, Inc. 558c94ec-95f1-eb98-e063-6394a90a1e72 2026-07-01 Warnings Exact identifier application number: M017 MUSCLE EASE MENTHOL CAMPHOR SOMBRA COSMETICS INC. 03fff4bf-04ed-49a6-b40f-4d98c2b42f69 2026-07-01 Warnings Exact identifier application number: M017 OrthoNesic Pain Relieving Gel MENTHOL, CAMPHOR Blaine Labs Inc. 122f60c2-f8df-4625-8bb8-a2244a261b5d 2026-07-01 Warnings Exact identifier application number: M017 Desert Harvest RELEVEUM LIDOCAINE Desert Harvest Inc. 5d9010ec-d482-44ff-ba27-3bfec5a241c6 2026-06-30 Warnings Exact identifier application number: M017 Promescent LIDICAINE Absorption 5b508238-3be7-4b0d-bf35-51de79f58f55 2026-06-30 Warnings Exact identifier application number: M017 Lidovyx LIDOCAINE 4% V2 Pharma LLC 4465eb60-a617-4608-9504-8b3b4c64f49e 2026-06-30 Warnings Exact identifier application number: M017 Dr.Johnes Lidocaine 4% Topical Analgesic Cream LIDOCAINE HCL,MENTHOL Dr.Johnes LLC 6144708d-4b0f-4f0d-88e3-6925ba2d004d 2026-06-29 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