FDA.reportPublic FDA data

ORGANIC PEPPERMINT HERB THROAT DROPS

Manufacturer
Ricola Ag
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:38

Label at a glance#

ProductORGANIC PEPPERMINT HERB THROAT DROPS
Active ingredientMENTHOL
Label structure9 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 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  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

Oral anesthetic

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 1.9 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional minor irritation and pain associated with:

  • sore mouth
  • sore throat

Warnings

WARNINGS SECTION

Do not use

  • in children under 6 years of age unless directed by a doctor.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.
  • sore mouth symptoms do not improve in 7 days.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  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 (ribwort plantain, lady's mantle, mallow, thyme, pimpinella, marshmallow, peppermint), peppermint oil, starch syrup, sugar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of BIO_KNOSPE_PFEMI_54G.jpgImage of BIO_KNOSPE_PFEMI_54G.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2264360menthol 1.9 MG Oral LozengePSN3
2264360menthol 1.9 MG Oral LozengeSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-010-15ORGANIC PEPPERMINT HERB THROAT DROPS15 in 1 BAGLOZENGE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-010ORGANIC PEPPERMINT HERB THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]3Current NDC, Legacy NDC, 1 package rows20241207_a6657ecf-e74a-4912-a68c-73abc456f9e2.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
54305-01054305-010-15

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
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
ndc (package): 54305-010-15
ndc (product): 54305-010
ndc11 (package): 54305001015
spl id: cffe288f-8bb5-464c-8423-7e37c1711aa4
spl set id: a6657ecf-e74a-4912-a68c-73abc456f9e2

Reported adverse events (FAERS/openFDA)#

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