COOL RELIEF LEMON FROST ORAL ANESTHETIC

Manufacturer
Ricola Ag
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:35

Label at a glance#

ProductCOOL RELIEF LEMON FROST 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, 16.0 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional minor irritation and pain associated with:

  • sore mouth
  • sore throat

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
  • do not bite or chew

Other Information

STORAGE AND HANDLING SECTION

protect from heat and moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, colors (carrot), extract of bee balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), honey, lemon juice concentrate, starch syrup, sugar.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cool_Relief_Lemon_Ricola19ct.jpgCool_Relief_Lemon_Ricola19ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2122215menthol 16 MG Oral LozengePSN3
2122215menthol 16 MG Oral LozengeSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-156-19COOL RELIEF LEMON FROST ORAL ANESTHETIC19 in 1 BAGLOZENGE193
54305-156-24COOL RELIEF LEMON FROST ORAL ANESTHETIC24 in 1 BAGLOZENGE243
54305-156-45COOL RELIEF LEMON FROST ORAL ANESTHETIC45 in 1 BAGLOZENGE453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-156COOL RELIEF LEMON FROST ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA AG]3Current NDC, Legacy NDC, 3 package rows20241207_908f5ce5-94a4-4c35-ae7a-b308ea37fa08.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54305-15654305-156-19, 54305-156-45, 54305-156-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
SUCROSEC151H8M554IACT
HONEYY9H1V576FHIACT
LEMON JUICEAGN709ANTJIACT

Source Document#

Source XML · Source PDF

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 LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
ndc (package): 54305-156-19
ndc (package): 54305-156-45
ndc (package): 54305-156-24
ndc (product): 54305-156
ndc11 (package): 54305015624
ndc11 (package): 54305015645
ndc11 (package): 54305015619
spl id: c40349c5-4746-4318-9f9b-68d60668a9f2
spl set id: 908f5ce5-94a4-4c35-ae7a-b308ea37fa08

Reported adverse events (FAERS/openFDA)#

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