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 122 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Exact identifier application number: M017
NATUREANCE MIRACLE	MENTHOL	EROS GLOBAL CORP	ec1a2a1f-a38d-9c59-e053-2a95a90ad268	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Plantar Relief Strips	CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	65e142d8-da21-4c55-9faf-b387cb6c2c0e	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	cc011b79-2761-40f7-8142-88f8e30a179a	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Profoot, Inc.	06f82bde-41a1-35f6-e063-6394a90a6437	2024-10-23	Warnings	Exact identifier application number: M017
Deep Cover Bug Bite Relief	BENZOCAINE	Morrisons Outdoors, LLC	25010dd6-fb48-8ee7-e063-6394a90aee6c	2024-10-21	Warnings	Exact identifier application number: M017
Evel Knievels Natural Choice Pain Relief	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	4576656c-4b6e-6965-7665-6c52756c6573	2024-10-21	Warnings	Exact identifier application number: M017
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	Warnings	Exact identifier application number: M017
DG Health Hydrocortisone Maximum Strength	HYDROCORTISONE	Dolgencorp Inc	2cc792b8-dce6-4178-bd6d-63ba268b7747	2024-10-19	Warnings	Exact identifier application number: M017
Careland Hydrogel Pain Relief Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	e970070c-1c3b-49f0-8298-e6c5ebbf50a0	2024-10-18	Warnings	Exact identifier application number: M017
Fruit of the Earth Cool Blue Aloe Mist Continuous	LIDOCAINE HYDROCHLORIDE	Fruit Of The Earth, Inc.	d4caae4c-efba-2453-e053-2995a90a5e5f	2024-10-18	Warnings	Exact identifier application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving	LIDOCAINE HCL	CVS Pharmacy	f0f1969d-10e0-76ee-e053-2995a90a7336	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wong To Yick Wood Lock Ointment Ltd	16a21af4-6bc0-4ae1-aa3b-1da84c8286e2	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wicsun Trading Inc	0b4bd444-b3c1-47aa-a7e3-f16c92326124	2024-10-17	Warnings	Exact identifier application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL	LIDOCAINE	Fruit of the Earth, Inc.	c7a833bd-7457-73a3-e053-2a95a90ac53f	2024-10-17	Warnings	Exact identifier application number: M017
Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic	LIDOCAINE HYDROCHLORIDE	WEGMANS FOOD MARKETS INC	f70bc438-7ed8-f74d-e053-6394a90a2b3f	2024-10-16	Warnings	Exact identifier application number: M017
EQUATE Sunburn relief with Aloe After Sun	LIDOCAINE	Wal-Mart Stores Inc	c25e1288-7ac6-41fc-ab65-26c379f288a7	2024-10-16	Warnings	Exact identifier application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ct	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	b119ba37-0ee1-851a-e053-2995a90a85b1	2024-10-15	Warnings	Exact identifier application number: M017
PAIN RELIEF PATCHES	LIDOCAINE	Walgreen Company	1a587e6e-88d1-4b01-abad-9a365dc64a4d	2024-10-15	Warnings	Exact identifier application number: M017
TopCare Everyday After Sun Cooling	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	baff7293-e1a3-d1f2-e053-2995a90a93ca	2024-10-15	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