FDA.reportPublic FDA data

COOL RELIEF ORAL ANESTHETIC

Manufacturer
Ricola Ag
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:36

Label at a glance#

ProductCOOL RELIEF ORAL ANESTHETIC
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

temporarily relieves: cough due to a cold or inhaled irritants occasional minor irritation and pain due to sore throat or sore mouth

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

Storage and handling

protect from heat and moisture

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 15.3 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings

WARNINGS SECTION

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

Other Information

STORAGE AND HANDLING SECTION

protect from heat and moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

Bulk Label

SPL UNCLASSIFIED SECTION

Image of Bulk Label img125 res.jpgImage of Bulk Label img125 res.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Cool Relief MFP08S-86.jpgImage of Cool Relief MFP08S-86.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54305-153-192020-02-10C16284748780-19d75b9d0-baac-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-242020-02-10C16284748780-19d75b9d0-baac-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-452020-02-10C16284748780-19d75b9d0-baac-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-192020-01-31C16284748780-19d75b9d0-baac-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-242020-01-31C16284748780-19d75b9d0-baac-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
54305-153-452020-01-31C16284748780-19d75b9d0-baac-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-153-19COOL RELIEF ORAL ANESTHETIC19 in 1 BAGLOZENGE196
54305-153-24COOL RELIEF ORAL ANESTHETIC24 in 1 BAGLOZENGE246
54305-153-45COOL RELIEF ORAL ANESTHETIC45 in 1 BAGLOZENGE456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-153COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]6Current NDC, Legacy NDC, 3 package rows20241207_951e9836-e6a3-4094-8a6b-f226c85c897a.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
54305-15354305-153-19, 54305-153-24, 54305-153-45

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 Ag951e9836-e6a3-4094-8a6b-f226c85c897a2024-12-05WarningsExact identifier
ndc (package): 54305-153-19
ndc (package): 54305-153-45
ndc (package): 54305-153-24
ndc (product): 54305-153
ndc11 (package): 54305015345
ndc11 (package): 54305015319
ndc11 (package): 54305015324
spl id: b19f8bc7-1e7c-4eed-a20c-cab9fa8929f4
spl set id: 951e9836-e6a3-4094-8a6b-f226c85c897a

Reported adverse events (FAERS/openFDA)#

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