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 147 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BODY ACTION PRODUCTS Endless Love for Men	BENZOCAINE	PRODUCT MAX GROUP INC	d0fa792d-dc04-4bdf-a22d-dea896beae5b	2023-11-10	Warnings	Exact identifier application number: M017
Endless Love For Men	BENZOCAINE	Body Action Products, Inc	4e89cd3a-ecad-44c3-acb3-6d0810add8c0	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Higher Control Male Climax	BENZOCAINE	PRODUCT MAX GROUP INC	3c7fa73b-abe8-4a8d-951c-4e785d6e812c	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	65a319a6-89d2-44c9-81d5-30327f9948cb	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	768f3f0e-1add-404f-b869-00a9f35ad34a	2023-11-10	Warnings	Exact identifier application number: M017
Zcaine Fast Acting Anesthetic	LIDOCAINE	PHI, Inc	d072243f-6ba6-4ab6-8ebf-a2381fa9c2df	2023-11-09	Warnings	Exact identifier application number: M017
Plum Smooth Plumb Numb Gelee	LIDOCAINE	Universal Companies, Inc.	6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e	2023-11-09	Warnings	Exact identifier application number: M017
Sonacaine Topical Anesthetic With Menthol	LIDOCAINE	Filltech USA, LLC	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	2023-11-09	Warnings	Exact identifier application number: M017
Bed Bug Instant Bite Relief	LIDOCAINE	P.F. Harris Mfg. Co. LLC	7f472fd0-5605-4cc6-b4b2-1267e815255c	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Aerobic Sports	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	33f2491e-c1f2-4e5a-acbe-8ace844b88d6	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Topical Analgesic Roll On	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	28167e2a-9afb-44e7-90c7-9577df9504b6	2023-11-09	Warnings	Exact identifier application number: M017
Satohap Cool Type	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	fe07a00a-2699-44d3-887d-bd068948ad7b	2023-11-07	Warnings	Exact identifier application number: M017
Hims Delay Wipes	BENZOCAINE WIPES	Hims Inc.	adbead3d-dca0-4919-b688-44c88f779e5a	2023-11-07	Warnings	Exact identifier application number: M017
Bakers Best Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	Baker's Best Health Products, LLC	9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed Oil	LIDOCAINE HYDROCHLORIDE, MENTHOL	BAKER'S BEST HEALTH PRODUCTS, INC.	ae54c234-bfe4-4a74-b293-db7efda7884b	2023-11-06	Warnings	Exact identifier application number: M017
Arth RX Topical Analgesic	METHYL NICOTINATE, CAPSAICIN	HCD Sales	a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender	HISTAMINE DIHYDROCHLORIDE	BAKER'S BEST HEALTH PRODUCTS, INC.	03ec87c5-6669-4afb-8d9c-c8dc9907495d	2023-11-06	Warnings	Exact identifier application number: M017
DOCTORS TOUCH Erase The Pain	MENTHOL	DOCTOR'S CHOICE MEDICAL, LLC	fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0	2023-11-06	Warnings	Exact identifier application number: M017
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort	MENTHOL	ACA MANAGEMENT LLC	5f52218d-eea4-4640-b820-84c077ab98ba	2023-11-06	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