FDA.reportPublic FDA data

Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant

Manufacturer
Lofthouse of Fleetwood, Ltd.
Effective date
2021-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:41:03

Label at a glance#

ProductOriginal Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants occasional minor sore throat

Dosage and administration

adults and children 2 to under 12 years of age: allow lozenge to dissolve slowly in the mouth may be repeated every hour as needed for cough, or every 2 hours as needed for sore throat, or as directed by a doctor children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Menthol 10 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant/oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

  • cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
  • occasional minor sore throat

Warnings

WARNINGS SECTION

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If sore throat is severe or persists more than 2 days accompanied by headache, nausea, and vomiting, contact a doctor right away. If sore mouth symptoms do not improve in 7 days, see your dentist of doctor promptly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION


  • adults and children 2 to under 12 years of age: allow lozenge to dissolve slowly in the mouth
  • may be repeated every hour as needed for cough, or every 2 hours as needed for sore throat, or as directed by a doctor
  • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original

Extra

Strong

Trial Size

Since Lofthouse's 1865

Fisherman's Friend

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

No Artificial Flavors or Ingredients

2 Lozenges

Manufactured by:

Lofthouse of Fleetwood Ltd., Lancs., England

Distributed by: Pez Candy Inc.

35 Prindle Hill Road, Orange, CT 06477

www.fishermansfriend.com

Original Extra Strong Trial SizeOriginal Extra Strong Trial Size

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014609Fisherman's Friend 10 MG Oral LozengePSN4
199393menthol 10 MG Oral LozengePSN4
1014609menthol 10 MG Oral Lozenge [Fisherman's Friend]SBD4
199393menthol 10 MG Oral LozengeSCD4
1014609Fisherman's Friend 10 MG Oral LozengeSY4
199393menthol 10 MG Oral PastilleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55711-064-05Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant2 in 1 PACKETLOZENGE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55711-064ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT (MENTHOL) LOZENGE [LOFTHOUSE OF FLEETWOOD, LTD.]4Current NDC, Legacy NDC, 1 package rows20210627_2299916d-9864-4176-bc77-fa35a0ed959b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
MentholACTIVE MOIETYL7T10EIP3A1
CapsicumINACTIVE INGREDIENT00UK7646FG1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI6621
LicoriceINACTIVE INGREDIENT61ZBX548831
Raw SugarINACTIVE INGREDIENT8M707QY5GH1
TragacanthINACTIVE INGREDIENT2944357O2O1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55711-06455711-064-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSICUM00UK7646FGIACT
EUCALYPTUS OIL2R04ONI662IACT
LICORICE61ZBX54883IACT
RAW SUGAR8M707QY5GHIACT
TRAGACANTH2944357O2OIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TragacanthTRAGACANTH2944357O2OTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET, COATED / ORAL7.5 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OPOWDER, FOR SUSPENSION / ORAL60 mg/1mlExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OPOWDER, FOR SUSPENSION / ORAL60 mg/1mlExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OSUSPENSION / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OSUSPENSION / ORAL130 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET / ORAL12 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET / ORAL12 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OSUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii+route
16 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OSUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OWAFER / ORAL32 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET, COATED / ORAL7.5 mgExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
TragacanthTRAGACANTH2944357O2OWAFER / ORAL32 mgExact identifier — unii+route
16 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route
2 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
ndc (package): 55711-064-05
ndc (product): 55711-064
ndc11 (package): 55711006405
c59e47a7-9635-0c5c-e053-2995a90a443c2299916d-9864-4176-bc77-fa35a0ed959b2021-06-25WarningsExact identifier
spl id: c59e47a7-9635-0c5c-e053-2995a90a443c
spl set id: 2299916d-9864-4176-bc77-fa35a0ed959b

Reported adverse events (FAERS/openFDA)#

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