FDA.reportPublic FDA data

DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC

Manufacturer
Ricola USA Inc. | Ricola Ag
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:42

Label at a glance#

ProductDUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC
Active ingredientMENTHOL
Label structure10 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, 8.3 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.

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

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 MFP08S-86.jpgImage of MFP08S-86.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1424614menthol 8.3 MG Oral LozengePSN4
1424614menthol 8.3 MG Oral LozengeSCD4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63667-603-192023-01-18C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-262023-01-18C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-192022-01-28C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-262022-01-28C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-192020-02-10C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-262020-02-10C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-192020-01-31C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-262020-01-31C16284748780-19d75b9cf-fa4c-f424-e053-dadaa90a57ceDUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-603-19DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC19 in 1 BAGLOZENGE194
63667-603-26DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC26 in 1 BAGLOZENGE264

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-603DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]4Current NDC, Legacy NDC, 2 package rows20241211_db2ab9be-507d-4768-9d00-188f751b7726.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63667-60363667-603-19, 63667-603-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
SUCROSEC151H8M554IACT
GLYCERINPDC6A3C0OXIACT

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
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.db2ab9be-507d-4768-9d00-188f751b77262024-12-10WarningsExact identifier
ndc (package): 63667-603-19
ndc (package): 63667-603-26
ndc (product): 63667-603
ndc11 (package): 63667060326
ndc11 (package): 63667060319
spl id: fdd9887a-22ba-4242-9c08-77f202dc6973
spl set id: db2ab9be-507d-4768-9d00-188f751b7726

Reported adverse events (FAERS/openFDA)#

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