XtraCare Ice Cold Topical Analgesic Gel

Product NDC: 57337-052
11-digit product format: 573370052
Labeler code: 57337
Product ID: 57337-052_087f5ceb-0e96-0c3a-e063-6394a90acfc7
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-30
Substance: MENTHOL
Active strength: 3 g/227g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: XtraCare Ice Cold Topical Analgesic Gel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	3 g/227g

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
866128	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
d38f3099-d940-44d8-aa7f-404157c5e0e3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-052-01	XtraCare Ice Cold Topical Analgesic Gel	227 g in 1 BOTTLE	GEL	227		9
57337-052-02	XtraCare Ice Cold Topical Analgesic Gel	227 g in 1 TUBE	GEL	227		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-052	XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]	9	Current NDC, Legacy NDC, 2 package rows	20231025_d38f3099-d940-44d8-aa7f-404157c5e0e3.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 134 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier application number: M017
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier application number: M017
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Exact identifier application number: M017
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Exact identifier application number: M017
meijer Cold Therapy Pain Relieving analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	fb163112-d84d-418d-a410-3214c0ee4b5a	2024-02-28	Warnings	Exact identifier application number: M017
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Exact identifier application number: M017
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Bryant Ranch Prepack	fcf48536-224e-4a3d-9124-770031823972	2024-02-22	Warnings	Exact identifier application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	8bc3956b-b82d-4ed3-8bc3-db0078466bbc	2024-02-22	Warnings	Exact identifier application number: M017
Promescent Delay Wipes	BENZOCAINE	Absorption	f0a5b6be-acc5-473c-9054-b9534e769db1	2024-02-20	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	721658dc-3b1d-43ff-9032-e96851633cf9	2024-02-19	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866128	menthol 1.25 % Topical Gel	PSN	d38f3099-d940-44d8-aa7f-404157c5e0e3	9
866128	menthol 0.0125 MG/MG Topical Gel	SCD	d38f3099-d940-44d8-aa7f-404157c5e0e3	9
866128	menthol 1.25 % Topical Gel	SY	d38f3099-d940-44d8-aa7f-404157c5e0e3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-052-01	57337005201	227 g in 1 BOTTLE (57337-052-01)	227 g	2014-01-30	0000-00-00	No	No	Current
57337-052-02	57337005202	227 g in 1 TUBE (57337-052-02)	227 g	2014-01-30		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Ice Cold Topical Analgesic Gel	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp.	2023-10-24	HUMAN OTC DRUG LABEL	9