COOL RELIEF ORAL ANESTHETIC

Manufacturer: Ricola USA Inc. | Ricola Ag
Effective date: 2024-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:41:34

Label at a glance#

ProductCOOL RELIEF ORAL ANESTHETIC

Active ingredientMENTHOL

Label structure8 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Cool Relief MFP08S-86.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63667-153-19	2020-02-10	C162847	48780-1	9d75b9d1-0279-f424-e053-dadaa90a57ce	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-153-24	2020-02-10	C162847	48780-1	9d75b9d1-0279-f424-e053-dadaa90a57ce	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-153-45	2020-02-10	C162847	48780-1	9d75b9d1-0279-f424-e053-dadaa90a57ce	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-153-19	2020-01-31	C162847	48780-1	9d75b9d1-0279-f424-e053-dadaa90a57ce	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-153-24	2020-01-31	C162847	48780-1	9d75b9d1-0279-f424-e053-dadaa90a57ce	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-153-45	2020-01-31	C162847	48780-1	9d75b9d1-0279-f424-e053-dadaa90a57ce	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63667-153-19	COOL RELIEF ORAL ANESTHETIC	19 in 1 BAG	LOZENGE	19	5
63667-153-24	COOL RELIEF ORAL ANESTHETIC	24 in 1 BAG	LOZENGE	24	5
63667-153-45	COOL RELIEF ORAL ANESTHETIC	45 in 1 BAG	LOZENGE	45	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63667-153	COOL RELIEF ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]	5	Current NDC, Legacy NDC, 3 package rows	20241211_3f93919f-e63e-470d-9d9a-f6ea3492c23d.zip

Products#

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

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

COOL RELIEF ORAL ANESTHETIC
MENTHOL
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63667-153	63667-153-19, 63667-153-24, 63667-153-45

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
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
SUCROSE	C151H8M554	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL RELIEF ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	3f93919f-e63e-470d-9d9a-f6ea3492c23d	2024-12-10	Warnings	Exact identifier ndc (package): 63667-153-24 ndc (package): 63667-153-19 ndc (package): 63667-153-45 ndc (product): 63667-153 ndc11 (package): 63667015319 ndc11 (package): 63667015324 ndc11 (package): 63667015345 spl id: cc708429-515c-421d-85da-07bc4c22a9ab spl set id: 3f93919f-e63e-470d-9d9a-f6ea3492c23d

Reported adverse events (FAERS/openFDA)#

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