FDA.reportPublic FDA data

Fishermans Friend

Product NDC
55711-101
11-digit product format
557110101
Labeler code
55711
Product ID
55711-101_53391c4d-ee2e-ade3-e063-6394a90ac77d
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Lofthouse of Fleetwood
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
Substance
MENTHOL
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Fishermans Friend
Brand name suffix
Orange Ginger
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311508Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53391c4d-ee2d-ade3-e063-6394a90ac77dAvailable on FDA.report

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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda OxyfusionHYDROGEN PEROXIDEGURUNANDA, LLC3be317b9-a5d8-b198-e063-6394a90af9852025-11-11WarningsExact identifier
application number: M022
GuruNanda Oral Pain ReliefMENTHOLGURUNANDA, LLC3b8f3562-0e46-bea4-e063-6294a90adb712025-11-11WarningsExact identifier
application number: M022
TopCare Cherry FlavorPHENOLTOPCO ASSOCIATES, LLC5d3f0610-deb4-4180-ae19-2c65ed2f368b2025-11-10WarningsExact identifier
application number: M022
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
application number: M022
Zilactin-BBENZOCAINEASCENT CONSUMER PRODUCTS, INC42eeb3d4-bac6-4e29-e063-6294a90a644d2025-11-06WarningsExact identifier
application number: M022
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC106b6115-d043-4050-80c6-1d82456dea022025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC4c278122-2643-46bf-9e44-11985210a16e2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCfee9969d-ad1a-4f44-9741-a0a44c9e11282025-11-06WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDETarget Corporation0ddf9945-147d-4b25-98a6-4e9f12a4656f2025-11-05WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.e6a312e5-17ac-46f0-8723-4e40eeecd69f2025-11-04WarningsExact identifier
application number: M022
PEROXY SHIELD MOUTH SORE1.5% HYDROGEN PEROXIDEDental Technologies, Inc.a72e433b-1b7d-4a0c-e053-2995a90a30c42025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ae628766-25b7-4b4f-abb8-a43faf2f44b92025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.719743f9-21fc-4568-b879-acdfa46394642025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ff0695a1-1d7d-4b51-97fd-689e56d914fe2025-11-04WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f7edf75c-cdba-4dde-bfc5-a04af34759d32025-11-03WarningsExact identifier
application number: M022
7 Select Oral Pain Maximum Strength ReliefBENZOCAINE7-ELEVEN, INC.f170a570-1c50-4b9a-be16-9b01bf5eaa742025-10-31WarningsExact identifier
application number: M022
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
application number: M022
Iodent Oral AnalgesicBENZOCAINEUnited Exchange Corp.63902125-f8dc-0ada-e053-2991aa0a7ce52025-10-30WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55711-101-08557110101088 PACKET in 1 CARTON (55711-101-08) / 20 LOZENGE in 1 PACKET8 packet2026-07-01NoNoCurrent