FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL, UNSPECIFIED FORM3.969 g/113.4g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808955Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d27fbc17-46b7-4d52-ba29-c99b6c63144aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-615-40ARCTIC RELIEF113.4 g in 1 TUBEGEL113.46
58980-615-40ARCTIC RELIEF1 in 1 BOXGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-615-40GM - Gram58980-615e44c4e78-2486-4b19-a55b-db3d3ddfc68312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Camphor (Synthetic)ACTIVE INGREDIENT5TJD82A1ETARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
MentholACTIVE INGREDIENTL7T10EIP3AARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
Camphor (Synthetic)ACTIVE MOIETY5TJD82A1ETARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
MentholACTIVE MOIETYL7T10EIP3AARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
carbomer homopolymer type cINACTIVE INGREDIENT4Q93RCW27EARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
FD&C blue NO. 1INACTIVE INGREDIENTH3R47K3TBDARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
FD&C yellow NO. 5INACTIVE INGREDIENTI753WB2F1MARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
ilex paraguariensis leafINACTIVE INGREDIENT1Q953B4O4FARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
trolamineINACTIVE INGREDIENT9O3K93S3TKARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1
waterINACTIVE INGREDIENT059QF0KO0RARCTIC RELIEF (MENTHOL AND CAMPHOR (SYNTHETIC)) GEL [STRATUS PHARMACEUTICALS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-615ARCTIC RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [STRATUS PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 2 package rows20241102_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 79 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
application number: M017
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
application number: M017
Blue-Emu Maximum Pain ReliefTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLCc863351a-951b-4f7c-a9c0-4289d702054a2025-09-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.02a65b25-78b2-4e29-9484-40e2228fb3842025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporatione90df2e5-2ef4-47dd-bd74-be9cea6d9d852025-09-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
application number: M017
SupreH Arnica Bruise CreamSUPREH ARNICA REMEDY PLUS BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3e41fc0e-54c3-2622-e063-6294a90a13c92025-09-07WarningsExact identifier
application number: M017
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL CreamPAIN RELIEF CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e08cc87-2385-0838-e063-6394a90abf9b2025-09-05WarningsExact identifier
application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL CreamCLINICAL CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e090b98-1db7-4174-e063-6394a90aa5392025-09-05WarningsExact identifier
application number: M017
ALCEMISTELIDOCAINE HCLPrice Team Ventures, LLC4383faaa-49cf-47b7-83a6-c2a94b6ff9b52025-09-05WarningsExact identifier
application number: M017
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
application number: M017
Sumifun PLANTAR RELIEF ROLL -ON4% LIDOCAINE, 1% MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd3c9ee60b-548a-979f-e063-6394a90a70b02025-09-03WarningsExact identifier
application number: M017
Meijer Capsaicin Heat PatchCAPSAICINMeijer Distribution3c465557-0a4f-fb72-e063-6294a90a1ef22025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC Ventures Corp DBA Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808955menthol 3.5 % Topical GelPSNd27fbc17-46b7-4d52-ba29-c99b6c63144a6
808955menthol 0.035 MG/MG Topical GelSCDd27fbc17-46b7-4d52-ba29-c99b6c63144a6
808955menthol 3.5 % Topical GelSYd27fbc17-46b7-4d52-ba29-c99b6c63144a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-615-40589800615401 TUBE in 1 BOX (58980-615-40) / 113.4 g in 1 TUBE1 tube2017-09-150000-00-00NoNoCurrent