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 128 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Real Time Pain Relief Maxx Topical Analgesic MENTHOL REAL TIME PRODUCTS, INC f45eb95a-2813-4124-bdb0-54e078a8237d 2024-08-20 Warnings Exact identifier application number: M017 Theracare Lidocaine Pain relief LIDOCAINE Veridian Healthcare 1d8a3679-637d-94c0-e063-6294a90a9ecf 2024-08-19 Warnings Exact identifier application number: M017 LidoSync LIDOCAINE, MENTHOL iON Pharma, LLC 200f883c-439a-3b99-e063-6394a90aed10 2024-08-19 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 09243a23-1f17-f77b-e063-6394a90a0b22 2024-08-19 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Scalp Relief Anti-itch HYDROCORTISONE CVS Health b5ef0005-8b76-4205-8be0-db3a7ed7d1c4 2024-08-19 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving Roll-On LIDOCAINE HCL Rite Aid Corporation 1406590c-667c-84eb-e063-6294a90a5052 2024-08-16 Warnings Exact identifier application number: M017 Nuvira CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10% Strand Health Group ff448183-03cf-df2d-e053-6394a90a77f0 2024-08-16 Warnings Exact identifier application number: M017 FLANAX METHYL SALICYLATE, MENTHOL, CAPSAICIN Belmora LLC 5e06c688-a086-4c1c-8dab-fcead61fef40 2024-08-13 Warnings Exact identifier application number: M017 Pain Relief MENTHOL Pain Relieving Spray Inc. 1f44466f-044f-70fe-e063-6294a90ad575 2024-08-09 Warnings Exact identifier application number: M017 Meijer Cold Therapy Pain Relieving MENTHOL Meijer Inc 1c5b55e3-f859-71b6-e063-6294a90a633b 2024-08-08 Warnings Exact identifier application number: M017 HealthWise Soothing Cold Therapy Gel MENTHOL 4% Veridian Healthcare 1f09ccdd-09d8-6a8d-e063-6394a90a184f 2024-08-08 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. fbbbcc67-b46d-d41a-e053-6294a90aa55d 2024-08-08 Warnings Exact identifier application number: M017 Cheezheng Pain Relief Cream MENTHOL Tibet Cheezheng Tibetan Medicine Co. Ltd 37279a3f-9207-4e4c-90d6-52735044f104 2024-08-07 Warnings Exact identifier application number: M017 CVS Health Hydrocortisone Anti Itch HYDROCORTISONE CVS Health 546a1b8a-8254-432a-85c4-38ebee5ad568 2024-08-07 Warnings Exact identifier application number: M017 SANTO REMEDIO Alivio Pain Relieving Lavender Scent LIDOCAINE HYDROCHLORIDE, MENTHOL SANTO REMEDIO LLC ab53c7f2-a768-4f36-89d6-e128a1a940c2 2024-08-05 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT CVS Health ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3 2024-08-02 Warnings Exact identifier application number: M017 Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Exact identifier application number: M017 Anti Itch Soothing 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE The Honey Pot Company LLC 8bfeea34-25d5-4721-a17f-d9f1d0084cc3 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Arthritis Achy Foot and Muscle METHYL SALICYLATE The Avon Company 1f440f60-cfc4-511e-e063-6294a90a87db 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Maximum Strength Cracked Heel BENZALKONIUM CHLORIDE, LIDOCAINE The Avon Company 1f45752e-4a55-431e-e063-6294a90aa57a 2024-08-01 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