COOL RELIEF LEMON FROST 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 00:41:34

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_Ricola19ctfinal.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2122215	menthol 16 MG Oral Lozenge	PSN	3
2122215	menthol 16 MG Oral Lozenge	SCD	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63667-156-19	COOL RELIEF LEMON FROST ORAL ANESTHETIC	19 in 1 PACKAGE	LOZENGE	19	3
63667-156-24	COOL RELIEF LEMON FROST ORAL ANESTHETIC	24 in 1 PACKAGE	LOZENGE	24	3
63667-156-45	COOL RELIEF LEMON FROST ORAL ANESTHETIC	45 in 1 PACKAGE	LOZENGE	45	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63667-156	COOL RELIEF LEMON FROST ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]	3	Current NDC, Legacy NDC, 3 package rows	20241211_40c3a80a-a116-4607-bb4a-c89d255ee076.zip

Products#

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

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

COOL RELIEF LEMON FROST ORAL ANESTHETIC
MENTHOL
SUCROSE
LEMON JUICE
HONEY

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63667-156	63667-156-19, 63667-156-24, 63667-156-45

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
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
SUCROSE	C151H8M554	IACT
LEMON JUICE	AGN709ANTJ	IACT
HONEY	Y9H1V576FH	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL RELIEF LEMON FROST ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	40c3a80a-a116-4607-bb4a-c89d255ee076	2024-12-10	Warnings	Exact identifier ndc (package): 63667-156-19 ndc (package): 63667-156-45 ndc (package): 63667-156-24 ndc (product): 63667-156 ndc11 (package): 63667015624 ndc11 (package): 63667015645 ndc11 (package): 63667015619 spl id: b0f2af0e-99ab-46ae-9b73-f30f88050d0c spl set id: 40c3a80a-a116-4607-bb4a-c89d255ee076

Reported adverse events (FAERS/openFDA)#

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