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 146 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPER BLUE STUFF Pain Relief Cream	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	066a2106-2e25-4df6-9a8d-4417ba190205	2023-11-10	Warnings	Exact identifier application number: M017
INVIGO FLEX Pain Relief Gel	MENTHOL	WYNNPHARM INC.	909e1d8c-c517-4d6a-8682-894f042c00f8	2023-11-10	Warnings	Exact identifier application number: M017
ARNIMAX Penetrating Pain Relief Gel	MENTHOL	WYNNPHARM INC.	3a31f805-19c6-4036-a663-ebef9b212007	2023-11-10	Warnings	Exact identifier application number: M017
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Exact identifier application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVING	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	da004500-5e48-487b-b96f-520a3094096c	2023-11-10	Warnings	Exact identifier application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	MENTHOL, METHYL SALICYLATE	Rexall Sundown, LLC	55c55f1c-d2b3-6363-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
NEUROFLEX Topical Pain Relieving Liquid	CAMPHOR (SYNTHETIC), MENTHOL	Almark Products Inc	6da3aa84-7a01-4041-8792-a4bbf49e6e4e	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR 60-second Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	3b74b542-202f-469e-8025-4372e95e6b01	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f8b8d1-a20b-54b0-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f92e71-fe2e-16f4-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M017
Teeter Renew Muscles Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	b90dc5b9-c31d-4770-a291-98d036ae8723	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR Foot and Leg Rub	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	57094238-506b-48c1-8eb9-fe904be80df0	2023-11-10	Warnings	Exact identifier application number: M017
SKIN A COOL Hydrocortisone Anti-Itch	HYDROCORTISONE	Ana-Cool, LLC	e3ea7406-e494-4038-9b28-8d0a28b4b834	2023-11-10	Warnings	Exact identifier application number: M017
Teeter reNEW MUSCLES Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	ebc777b0-d141-4a62-9366-d14787eaefe0	2023-11-10	Warnings	Exact identifier application number: M017
FEELGOOD LAB Natural Pain Cream	MENTHOL	The Feel Good Lab, LLC	799d464c-aaf1-429a-877b-2a692397bb49	2023-11-10	Warnings	Exact identifier application number: M017
HIGHER CONTROL Male Climax Control Lubricating	BENZOCAINE	Product Max Group Inc	5f5fd127-34c5-403a-aa95-c9874ae79492	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f93076-1f68-58e6-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f9622e-27c7-6a5d-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
FEEL GOOD LAB Natural Pain Cream	MENTHOL	THE FEEL GOOD LAB, LLC	774a72b1-b719-4217-846e-7f9921fd1b16	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Climax Control Gel	BENZOCAINE	PRODUCT MAX GROUP INC	53e746cc-0078-4381-bf0b-9c8f98d66904	2023-11-10	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