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 132 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	0e808f89-62dc-3790-e063-6394a90a2351	2024-05-13	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold Gel	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1794c512-5f42-4ec3-e063-6394a90a87cd	2024-05-03	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro	MENTHOL AND CAMPHOR	ACTIVE AND INNOVATIVE, LLC	17961a84-6bee-c75f-e063-6394a90af576	2024-05-03	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Exact identifier application number: M017
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 Bulk	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	17545078-05e1-9338-e063-6394a90a678c	2024-04-30	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Roll-on	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1755ec89-c404-1c17-e063-6394a90ab9fb	2024-04-30	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Tube	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bec1d4-2e18-4519-e053-2a95a90a1bbb	2024-04-29	Warnings	Exact identifier application number: M017
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Cream	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	16f26249-b508-2c6e-e063-6394a90a265b	2024-04-25	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	JHK Inc	5a4ac4cc-015a-48e7-81f8-93a895049afd	2024-04-25	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	ede15818-5d17-477d-a8be-7b36bb0770a6	2024-04-22	Warnings	Exact identifier application number: M017
Anti Itch	HYDROCORTISONE	Neilmed Pharmaceuticals Inc.	14b4f066-fde4-ac97-e063-6394a90ae64c	2024-04-20	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relief Patch	MENTHOL 5%	Walgreens Company	e33c90d1-2729-970f-e053-2995a90ad97a	2024-04-18	Warnings	Exact identifier application number: M017
HealthWise Cold Therapy Pain Relief Patch	MENTHOL	Veridian Healthcare	0ce356e0-90a3-ad52-e063-6294a90a404a	2024-04-18	Warnings	Exact identifier application number: M017
Walgreens Scalp Relief External analgesic	HYDROCORTISONE	Walgreen Company	da0a24c7-9295-4f22-b2c7-40000dad4b81	2024-04-18	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