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 37 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF PATCHES	LIDOCAINE	WALMART STORES INC	b82cfe42-f521-4784-8c60-98481524c5ec	2026-01-29	Warnings	Exact identifier application number: M017
Equate Pain Relief Patch Camphor/Menthol/Salicylate	CAMPHOR, MENTHOL, METHYL SALICYLATE	Walmart Stores Inc	b869848c-21e2-5ca2-e053-2995a90a86f2	2026-01-29	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	498cd2aa-ee59-67b5-e063-6294a90ac242	2026-01-29	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	498d76d8-788b-4cc7-e063-6294a90a1696	2026-01-29	Warnings	Exact identifier application number: M017
MQUPIN Lidocaine Gel-Patch	LIDOCAINE GEL-PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	49703717-69a6-e480-e063-6394a90ac69c	2026-01-28	Warnings	Exact identifier application number: M017
MQXUNMI LIDOCAINE Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	49706db7-bacd-190f-e063-6394a90a3a8e	2026-01-28	Warnings	Exact identifier application number: M017
Joint and Muscle Relief Topical Analgesic	MENTHOL	Smart Cookie Solutions	1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d	2026-01-28	Warnings	Exact identifier application number: M017
VonaFlex Effective Pain Relief Topical Analgesic	LIDOCAINE HYDROCHLORIDE	OPTIMAL LABORATORIES, LLC	0901244a-7d41-413a-b424-92a807532f28	2026-01-28	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF	Dynarex	960e4240-cd09-2560-e053-2a95a90a7bcf	2026-01-28	Warnings	Exact identifier application number: M017
ALOE ICE SUNBURN RELIEF	LIDOCAINE HYDROCHLORIDE	Aloe Care International, LLC	56866fa8-052e-497c-a954-978d7d628949	2026-01-28	Warnings	Exact identifier application number: M017
Walgreens Original Strength Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Walgreen Company	a6a49dbb-74c7-47ca-88f2-3bb3d9acf914	2026-01-28	Warnings	Exact identifier application number: M017
Flobow QUIT SMOKING Nicotine	NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE	Jiangxi Yudexi Pharmaceutical Co., LTD	495b10ce-3d2d-1aa4-e063-6294a90a4f35	2026-01-27	Warnings	Exact identifier application number: M017
PAIN	REUSEABLE PAIN	Shenzhen Mengyue Technology Co., Ltd.	44e058fc-e1c0-742b-e063-6294a90ad225	2026-01-27	Warnings	Exact identifier application number: M017
HealthWise Pain Relieving Cream Lavender	MENTHOL	Veridian Healthcare	495eb6e9-69da-f7b6-e063-6294a90accee	2026-01-27	Warnings	Exact identifier application number: M017
HealthWise Pain Relieving Cream	MENTHOL	Veridian Healthcare	49548ab2-267e-1e2a-e063-6394a90ab391	2026-01-27	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores, Inc.	03feaaef-7401-d464-e063-6294a90a2b2d	2026-01-27	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	4a113699-1eb7-49b8-8cdf-2ad57db89b81	2026-01-27	Warnings	Exact identifier application number: M017
Healthy Back Institute Rub On Relief	ANALGESIC	Fullstack Fulfillment	284c29a3-5722-ce70-e063-6394a90a7fa0	2026-01-26	Warnings	Exact identifier application number: M017
Velocx for Joint and Muscle Pain Roll-On Applicator	MENTHOL, METHYL SALICYLATE	JMAD Consulting LLC, dba JMAD Labs	dbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d21	2026-01-26	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS	CAPSAICIN	Meijer Distribution Inc	9b91658f-c15f-4222-bbd9-881b29de3b6e	2026-01-26	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