FDA.reportPublic FDA data

Coralite Medicated Heat

Product NDC
65923-123
11-digit product format
659230123
Labeler code
65923
Product ID
65923-123_4278b319-7062-610a-e063-6394a90a2291
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-10
Substance
CAPSAICIN
Active strength
249 mg/1
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 Medicated Heat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN249 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0b89c7e-80bc-43c4-840c-5fd567f60b21Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-123-01Coralite Medicated Heat249 in 1 PATCHPATCH24912
65923-123-01Coralite Medicated Heat1 in 1 POUCHPATCH112
65923-123-02Coralite Medicated Heat2 in 1 POUCHPATCH212
65923-123-02Coralite Medicated Heat249 in 1 PATCHPATCH24912

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-123CORALITE MEDICATED HEAT (CAPSAICIN) PATCH [UNITED EXCHANGE CORP.]10Current NDC, Legacy NDC, 4 package rows20241222_a0b89c7e-80bc-43c4-840c-5fd567f60b21.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 34 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.2f272d12-7b34-430e-817e-1005f57ed9e92026-02-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA CORP4303fd30-0d35-3671-e063-6394a90a2aee2026-02-09WarningsExact identifier
application number: M017
Pain Relief LidocaineLIDOCAINEKroger Company4098756e-3d9f-317a-e063-6394a90af04c2026-02-09WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey4a698246-05a6-d01f-e063-6294a90a34012026-02-09WarningsExact identifier
application number: M017
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINEEbanel Laboratories, Inc41292d65-dabe-4bc3-872f-34a3912aa3422026-02-09WarningsExact identifier
application number: M017
DERMFREE NEUROPATHYARNICA MONTANA 1X HPUS 7% NEUROPATHYJiangxi Yudexi Pharmaceutical Co., LTD4a5c232d-5d29-2504-e063-6394a90ac9de2026-02-08WarningsExact identifier
application number: M017
ASSIELF NUMBING Topical AnorectalLIDOCAINEShenzhen Yuanbang International Logistics Co., Ltd4a5cb477-57ef-2a1d-e063-6394a90ac9ed2026-02-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieve Gel-PatchPAIN RELIEVE GEL-PATCHHenan Kangdi Medical Devices Co., Ltd1e31b950-e990-e255-e063-6394a90a7d232026-02-07WarningsExact identifier
application number: M017
Herbal Knee PatchHERBAL KNEE PATCHHenan Kangdi Medical Devices Co., Ltd2a009059-b515-8214-e063-6294a90a4ed32026-02-07WarningsExact identifier
application number: M017
Flocean ANTI-ITCHBENZOCAINE 5%ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a493911-a846-5aa0-e063-6294a90a65ac2026-02-07WarningsExact identifier
application number: M017
daily solutions Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMGarcoa, Inc.4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e62026-02-06WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEShenzhen Wankelai E-commerce Co., Ltd.4a22562b-601e-97d7-e063-6394a90a5bca2026-02-06WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESportpharm LLCee64ad1e-78db-4553-a3cf-b539b770fa262026-02-06WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Sportpharm LLC1dd022b9-88ae-4737-88cc-fdb0ce0a83a32026-02-06WarningsExact identifier
application number: M017
Camphor plus Lidocaine Pain ReliefCAMPHOR, LIDOCAINEVeridian Healthcare4a2b73a8-c10c-85f9-e063-6294a90ac52c2026-02-06WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLRetail Business Services, LLC073c72fe-3171-4a4f-913a-d1b9630a1af32026-02-06Warnings, Adverse reactionsExact identifier
application number: M017
HealthWise Soothing Lidocaine Pain ReliefLIDOCAINE HCI 0.5%Veridian Healthcare4a2ec73e-7332-6f13-e063-6294a90a85062026-02-06WarningsExact identifier
application number: M017
5 Elementum Delay WipesBENZOCAINE DELAY WIPESMSVenturesGroup O440539b0-612b-3b41-e063-6294a90a1ddd2026-02-05WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION4a156400-7001-d00d-e063-6294a90aa7142026-02-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSNa0b89c7e-80bc-43c4-840c-5fd567f60b2112
1043399capsaicin 0.00025 MG/MG Medicated PatchSCDa0b89c7e-80bc-43c4-840c-5fd567f60b2112
1043399capsaicin 0.025 % Medicated PatchSYa0b89c7e-80bc-43c4-840c-5fd567f60b2112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-123-01659230123011 PATCH in 1 POUCH (65923-123-01) / 249 PATCH in 1 PATCH1 patch2018-10-300000-00-00NoNoCurrent
65923-123-02659230123022 PATCH in 1 POUCH (65923-123-02) / 249 PATCH in 1 PATCH2 patch2016-02-100000-00-00NoNoCurrent