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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d27fbc17-46b7-4d52-ba29-c99b6c63144a	Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-615-40	GM - Gram	58980-615	e44c4e78-2486-4b19-a55b-db3d3ddfc683	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 90 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37ef02d4-2ff5-cb23-e063-6294a90a68af	2025-06-19	Warnings	Exact identifier application number: M017
Post-Treatment Repair Cream	HYDROCORTISONE	Vi Medical Products Inc.	ab8885a9-0778-28ff-e053-2995a90a2e12	2025-06-19	Warnings	Exact identifier application number: M017
MyDerm	LIDOCAINE	Inspec Solutions LLC.	82d075d1-c92e-2097-e053-2991aa0ab131	2025-06-18	Warnings	Exact identifier application number: M017
Walgreens Extra Small Lidocaine	LIDOCAINE	Walgreen Co.	dc838e47-d234-4ba5-9449-f645e99be923	2025-06-18	Warnings	Exact identifier application number: M017
CLn Body Moisturizer	COLLOIDAL OAT MOISTURIZER	TopMD Skin Care, Inc.	2de3d68d-a540-d456-e063-6394a90a4b57	2025-06-18	Warnings	Exact identifier application number: M017
Aloe UP SPF 30 Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Aloe Care International, LLC	35967b33-bdfb-ee3c-e063-6294a90a75f6	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Aloe Care International, LLC	35b9dcfa-05f3-3d7b-e063-6394a90a18f1	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Mineral	ZINC OXIDE	Aloe International, LLC	35bc3621-f4e4-42d3-e063-6394a90a7aad	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Kids Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Aloe Care International, LLC	35cd16b0-bd81-8f68-e063-6294a90a3d8c	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Kids Mineral	ZINC OXIDE	Aloe International, LLC	35cd5542-947d-a042-e063-6394a90a13f8	2025-06-18	Warnings	Exact identifier application number: M017
Relieve Your Pain	MENTHOL	Proximity Capital Partners LLC dba Asutra	c12369dd-8305-edaf-e053-2995a90a0d3d	2025-06-18	Warnings	Exact identifier application number: M017
Melt Pain Away	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	a95a11d7-a2ae-6654-e053-2a95a90a802c	2025-06-18	Warnings	Exact identifier application number: M017
Recovery Roll-On	MENTHOL, CAMPHOR	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	ebc9630f-6d8b-e4f0-e053-2995a90a0b49	2025-06-18	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37cdfabc-1fdb-246a-e063-6394a90a008a	2025-06-17	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37ce6c35-b211-43de-e063-6294a90ab773	2025-06-17	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	Sun Pharmaceutical Industries, Inc.	312ddc8d-100e-cfac-e063-6294a90acd09	2025-06-16	Warnings	Exact identifier application number: M017
Curist 5% Lidocaine	LIDOCAINE 5%	Little Pharma, Inc.	f20241a2-c5b1-f124-e053-2995a90a891b	2025-06-16	Warnings	Exact identifier application number: M017
Toast Screamin Menthol	MENTHOL	IDEAZ, LLC	37b48b1a-ef3d-afdc-e063-6294a90a6610	2025-06-16	Warnings	Exact identifier application number: M017
Toast Freezin Cold	MENTHOL, METHYL SALICYLATE	IDEAZ, LLC	37b4d363-0099-8cd3-e063-6394a90a18d6	2025-06-16	Warnings	Exact identifier application number: M017
Earths Care Anti-Itch	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	ba65f58a-d590-498a-b8e7-a3d78935d880	2025-06-13	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
808955	menthol 3.5 % Topical Gel	PSN	d27fbc17-46b7-4d52-ba29-c99b6c63144a	6
808955	menthol 0.035 MG/MG Topical Gel	SCD	d27fbc17-46b7-4d52-ba29-c99b6c63144a	6
808955	menthol 3.5 % Topical Gel	SY	d27fbc17-46b7-4d52-ba29-c99b6c63144a	6

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARCTIC RELIEF	STRATUS PHARMACEUTICALS INC \| TARMAC PRODUCTS INC	2024-10-31	HUMAN OTC DRUG LABEL	6