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 36 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbsure LIDOCAINE	LIDOCAINE 4%	Hambli Limited	43a65a12-ef2a-4608-e063-6394a90a82ea	2026-01-31	Warnings	Exact identifier application number: M017
Collajoint Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF GEL PATCH	Henan Enokon Medical Instrument Co., Ltd.	44e27e7f-992f-d194-e063-6294a90a94e4	2026-01-31	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT Patch	CAPSAICIN HEAT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac2045-2c07-af9a-e063-6294a90a052a	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac6a7b-25d3-6dc4-e063-6394a90a99b6	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49aca763-be2a-cf38-e063-6294a90a092e	2026-01-31	Warnings	Exact identifier application number: M017
PAIN RELIEF HOT Patch	PAIN RELIEF HOT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ad128a-0f4c-085a-e063-6294a90ac9bb	2026-01-31	Warnings	Exact identifier application number: M017
Walgreens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	3557d2e9-714a-4066-aa73-ea9e3363e574	2026-01-30	Warnings	Exact identifier application number: M017
Alveora HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4996f96a-898e-de01-e063-6394a90a3907	2026-01-30	Warnings	Exact identifier application number: M017
Sunburn Relief	LIDOCAINE HCL 0.5%	Rite Aid Corporation	b67af0c7-1ae8-4494-bb0e-d7f66ebca352	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS	CAPSAICIN	OL PHARMA TECH,LLC	48fdf9dc-05df-866d-e063-6294a90ae03a	2026-01-30	Warnings	Exact identifier application number: M017
ROCKTAPE GO Kinesiology Tape and Analgesic	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	b779c7d8-dbe6-472f-9282-6cced25cfd2e	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	de5f7add-1f2b-438a-ac17-753ebb53e697	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll-On	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	5a2d9c3a-67fc-4c1a-b1e8-62a93880397a	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Dr. Collado	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A	c0dad2db-7c96-49b8-a451-bf8cfa7f798b	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	3121c7f7-d7e5-4ca9-9057-03edf9c94c56	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A.	87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d	2026-01-29	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone Cream Plus	HYDROCORTISONE	Rooftop Consumer Health, Inc.	fe334cae-e019-4397-8498-df3c923ae8b5	2026-01-29	Warnings	Exact identifier application number: M017
Red Oil Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL, PHENOL	The Red Oil Company Inc	1e36579a-72da-46ba-ac72-5960a11c0880	2026-01-29	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM, MENTHOL	NATURES FORMULAE HEALTH PRODUCTS LTD.	498a5e2a-4de0-561c-e063-6394a90ac05c	2026-01-29	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET POTENT PAIN RELIEF	45c76956-db3f-3e84-e063-6394a90adce1	2026-01-29	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