FDA.reportPublic FDA data

Coralite Pain Relief Extra Strength Hot Patch 2ct 90152 (90152, 2021)

Manufacturer
United Exchange Corporation
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:40:16

Label at a glance#

ProductCoralite Pain Relief Hot
Active ingredientMENTHOL, CAPSAICIN
Label structure14 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F) avoid storing product in direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient Purpose

Capsicum extract 0.17 mg as Capsaicin........Topical analgesic

Menthol 30 mg....................................................Topical analgesic

OTC - PURPOSE SECTION

Uses

temporarily relieves minor pain of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

WARNINGS SECTION

Warnings

For external use only

Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present or irritation or rash develops
  • a severe burning sensation occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • adults and children 18 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • removed patch from the skin after 8 hours application
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-814-8028 monday-Friday 9AM-5PM (PST)

DOSAGE & ADMINISTRATION SECTION

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made In China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90152.190152.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1484488capsaicin 8.3 MG / menthol 30 MG in 1 GM Medicated PatchPSN5
1484488capsaicin 0.0083 MG/MG / menthol 0.03 MG/MG Medicated PatchSCD5
1484488capsaicin 0.83 % / menthol 3 % Medicated PatchSY5
1484488capsaicin 8.3 MG / menthol 30 MG per 1 GM Medicated PatchSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130780707901526GTIN-13: 0780707901526
EAN-13: 0780707901526
GTIN-12: 780707901526
UPC-A: 780707901526
GTIN storage (14 digits): 00780707901526		90152.1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-146-02Coralite Pain Relief Hot1 g in 1 PATCHPATCH15
65923-146-02Coralite Pain Relief Hot2 in 1 POUCHPATCH25

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-14665923-146-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
TARTARIC ACIDW4888I119HIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
MENTHOLL7T10EIP3AACTIB
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
CAPSAICINS07O44R1ZMACTIB
SORBITAN MONOOLEATE06XEA2VD56IACT
KAOLIN24H4NWX5COIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-20full-release2026-06-01 00:47:34

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
ndc (package): 65923-146-02
ndc (product): 65923-146
ndc11 (package): 65923014602
spl id: 41dc963f-67e2-e705-e063-6394a90a2b96
spl set id: 78eb133d-01bb-6466-e053-2991aa0accc0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.