FDA.reportPublic FDA data

Coralite Ultra Strength Pain Relief

Manufacturer
United Exchange Corp.
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:41:20

Label at a glance#

ProductCoralite Ultra Strength Pain Relief
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure13 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                                       Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic

OTC - PURPOSE SECTION

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with
  • simple backache
  • arthritis
  • strains
  • bruise
  • sprains

WARNINGS SECTION

Warnings

For external use only

Allergy alert: This product may cause allergic reaction in some individuals. Test on small area before use.

OTC - DO NOT USE SECTION

Do not use

  • on wounds, damaged or irritated skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • on a child under 12 years of age with arthritis-like conditions

OTC - WHEN USING SECTION

When using this product

  • do not use otherwise than 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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a healthcare 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 immediately

INDICATIONS & USAGE SECTION

Directions

  • adults and children 12 years of age and older:
  • rub well on the affected area. Repeat 3 to 4 times daily.
  • children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

clove oil, paraffin, peppermint oil, petrolatum

DOSAGE & ADMINISTRATION SECTION

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

1-888-645-8204

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

532.1532.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1089831camphor 11 % / menthol 11 % Topical CreamPSN13
1089831camphor 110 MG/ML / menthol 110 MG/ML Topical CreamSCD13
1089831camphor 11 % / menthol 11 % Topical CreamSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130780707005323GTIN-13: 0780707005323
EAN-13: 0780707005323
GTIN-12: 780707005323
UPC-A: 780707005323
GTIN storage (14 digits): 00780707005323		532.1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-532-182022-03-31C16284748780-1d6a99b39-7496-a426-e053-dadaa90af4c2Coralite Ultra Strength Pain Relief Balm 0.63oz (532)
65923-532-182022-03-31C16284748780-1d6a99b39-7496-a426-e053-dadaa90af4c2Coralite Ultra Strength Pain Relief Balm 0.63oz (532)
65923-532-182022-01-28C16284748780-1d6a99b39-7496-a426-e053-dadaa90af4c2Coralite Ultra Strength Pain Relief Balm 0.63oz (532)
65923-532-182022-01-28C16284748780-1d6a99b39-7496-a426-e053-dadaa90af4c2Coralite Ultra Strength Pain Relief Balm 0.63oz (532)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-532-18Coralite Ultra Strength Pain Relief1 in 1 CARTONOINTMENT113
65923-532-18Coralite Ultra Strength Pain Relief18 g in 1 JAROINTMENT1813

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
CAJUPUT OILINACTIVE INGREDIENTJ3TO6BUQ371
CLOVE OILINACTIVE INGREDIENT578389D6D01
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-53265923-532-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
CLOVE OIL578389D6D0IACT
PETROLATUM4T6H12BN9UIACT
PARAFFINI9O0E3H2ZEIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-12-20full-release2026-06-01 00:47:25

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
ndc (package): 65923-532-18
ndc (product): 65923-532
ndc11 (package): 65923053218
spl id: 425530d6-e8ea-f05c-e063-6294a90aff39
spl set id: 44ecf959-cc07-4adc-a500-075b2ee69548

Reported adverse events (FAERS/openFDA)#

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