FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL3 g/227g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866128Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d38f3099-d940-44d8-aa7f-404157c5e0e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-052-01XtraCare Ice Cold Topical Analgesic Gel227 g in 1 BOTTLEGEL2279
57337-052-02XtraCare Ice Cold Topical Analgesic Gel227 g in 1 TUBEGEL2279

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
MENTHOLACTIVE MOIETYL7T10EIP3AXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-052XTRACARE ICE COLD TOPICAL ANALGESIC GEL (MENTHOL) GEL [REJOICE INTERNATIONAL]9Current NDC, Legacy NDC, 2 package rows20231025_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 130 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact identifier
application number: M017
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866128menthol 1.25 % Topical GelPSNd38f3099-d940-44d8-aa7f-404157c5e0e39
866128menthol 0.0125 MG/MG Topical GelSCDd38f3099-d940-44d8-aa7f-404157c5e0e39
866128menthol 1.25 % Topical GelSYd38f3099-d940-44d8-aa7f-404157c5e0e39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-052-0157337005201227 g in 1 BOTTLE (57337-052-01) 227 g2014-01-300000-00-00NoNoCurrent
57337-052-0257337005202227 g in 1 TUBE (57337-052-02) 227 g2014-01-30NoNoCurrent