FDA.reportPublic FDA data

Coralite Pain Relief

Product NDC
65923-564
11-digit product format
659230564
Labeler code
65923
Product ID
65923-564_41b49d77-4471-c6ae-e063-6394a90aaac6
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-12
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
1.2; 5.7; 6.3 g/100g; g/100g; g/100g
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
Coralite Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)1.2 g/100g
MENTHOL5.7 g/100g
METHYL SALICYLATE6.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
853260Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69aec845-3d4c-d226-e053-2991aa0afd12Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-31Coralite Pain Patch 20 ct. 90156
2022-03-31Coralite Small Pain Relief Patch 20 ct. 90156
2022-01-28Coralite Pain Patch 20 ct. 90156
2022-01-28Coralite Small Pain Relief Patch 20 ct. 90156

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-564-20Coralite Pain Relief20 in 1 PACKAGEPATCH2010
65923-564-20Coralite Pain Relief1 g in 1 PATCHPATCH110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-564CORALITE PAIN RELIEF (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [UNITED EXCHANGE CORP.]8Current NDC, Legacy NDC, 2 package rows20250207_69aec845-3d4c-d226-e053-2991aa0afd12.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 93 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaRad ReliefLIDOCAINE EMULSIONRENU LABORATORIES, LLCd5e11f73-918b-eeac-e053-2995a90a4a832025-05-06WarningsExact identifier
application number: M017
Plantar Fasciitis Pain Relief Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd34838622-b092-afeb-e063-6294a90ae7db2025-05-06WarningsExact identifier
application number: M017
Climax Shield DelayBENZOCAINEPRODUCT MAX GROUP INC9c720cdc-f753-47ce-95ff-3b26e461a0ab2025-05-05WarningsExact identifier
application number: M017
PediFix Lidocaine Pain-Relief PatchesLIDOCAINE PAIN-RELIEF PATCHESPediFix, Inc346550b9-d2ba-184e-e063-6394a90a591a2025-05-05WarningsExact identifier
application number: M017
Walgreens Stop Itch GelDIPHENHYDRAMINE HCLWalgreens Co23586336-8f46-3dcd-e063-6394a90accc92025-05-04WarningsExact identifier
application number: M017
WaxRx EarAcheRx Pain Relieving Drops4% LIDOCAINE HCLDOCTOR EASY MEDICAL PRODUCTS, LLC34156655-8706-f0a4-e063-6294a90acc902025-05-01WarningsExact identifier
application number: M017
foster and thrive anti itch creamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEStrategic Sourcing Services LLCbb08293d-5db8-4cc8-9fe3-bd02061dbeb92025-04-30WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINESolis Pharmaceuticals Inc.3061d301-2104-b1b2-e063-6394a90a9b6e2025-04-29WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEInterMed Laboratories Private Limited33ed754e-8852-d5b2-e063-6394a90a7cf22025-04-29WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee6e48-243e-4ded-e063-6394a90a987d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd32b96689-8e9b-4c2e-e063-6294a90a7d1c2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3304e362-dcda-3f5e-e063-6294a90a70152025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2f2f753d-c791-e863-e063-6394a90aec5d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3162c96a-061d-2971-e063-6394a90a9b742025-04-29WarningsExact identifier
application number: M017
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-onMENTHOLVeridian Healthcare33dae8a8-4197-f276-e063-6294a90aea832025-04-28WarningsExact identifier
application number: M017
HealthWise Roll-on Menthol Pain Relief GelMENTHOLVeridian Healthcare33dbb939-9397-7e70-e063-6294a90ac8f42025-04-28WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.fa1a98bc-c233-410d-a20e-71111c8973722025-04-28WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Medcore LLCb961906c-fe66-466b-af2c-072781fa098b2025-04-28WarningsExact identifier
application number: M017
Walgreens Lidocaine Knee and ElbowLIDOCAINEWalgreen Co.a3fb4c78-1493-4ba4-ae83-502dd825ed672025-04-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN69aec845-3d4c-d226-e053-2991aa0afd1210
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD69aec845-3d4c-d226-e053-2991aa0afd1210
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY69aec845-3d4c-d226-e053-2991aa0afd1210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-564-206592305642020 PATCH in 1 PACKAGE (65923-564-20) / 1 g in 1 PATCH20 patch2018-04-120000-00-00NoNoCurrent