FDA.reportPublic FDA data

COOL RELIEF ORAL ANESTHETIC

Manufacturer
Ricola USA Inc. | Ricola Ag
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:41:42

Label at a glance#

ProductCOOL RELIEF ORAL ANESTHETIC
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

temporarily relieves occasional minor irritation and pain associated with sore mouth sore throat

Dosage and administration

adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor children under 6 years: ask a doctor do not bite or chew

Storage and handling

protect from heat and moisture

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 13.2 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional minor irritation and pain associated with

  • sore mouth
  • sore throat

Warnings

WARNINGS SECTION

Do not use

  • in children under 5 years of age unless directed by a doctor

Sore throat warnings:

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
  • do not bite or chew

Other Information

STORAGE AND HANDLING SECTION

protect from heat and moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Cool Relief Stick resave.jpgImage of Cool Relief Stick resave.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277805menthol 13.2 MG Oral LozengePSN3
2277805menthol 13.2 MG Oral LozengeSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-513-10COOL RELIEF ORAL ANESTHETIC10 in 1 PACKAGELOZENGE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-513COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]3Current NDC, Legacy NDC, 1 package rows20241211_d66f47a9-35ab-4bf9-8065-c81abcb503f5.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63667-51363667-513-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

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
COOL RELIEF ORAL ANESTHETICMENTHOLRicola USA Inc.d66f47a9-35ab-4bf9-8065-c81abcb503f52024-12-10WarningsExact identifier
ndc (package): 63667-513-10
ndc (product): 63667-513
ndc11 (package): 63667051310
spl id: c1038250-ebbe-4fd8-a0f0-030a9209d7ff
spl set id: d66f47a9-35ab-4bf9-8065-c81abcb503f5

Reported adverse events (FAERS/openFDA)#

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