FDA.reportPublic FDA data

Medique Sugar Free Medikoff Drops

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:12:58

Label at a glance#

ProductMedique Sugar Free Medikoff Drops
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each drop)

Menthol 5.8 mg

OTC - PURPOSE SECTION

Purpose

Antitussive (cough suppressant)/oral anesthetic

INDICATIONS & USAGE SECTION

Uses

temporarily relieves

■ cough as may occur with a cold or inhaled irritants

■ occasional minor irritation and sore throat

WARNINGS SECTION

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • cough persists for more than 7 days, 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use more than directed

​Adults and Children (12 years and older)

​Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

  • 7 calories per drop
  • store at 59º-86ºF (15º-30ºC)
  • protect from moisture & heat

INACTIVE INGREDIENT SECTION

Inactive ingredients

acesulfame potassium, eucalyptus oil, flavoring, isomalt

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

Medique Medikoff Sugar Free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique ®

Sugar Free Medikoff Drops

Vapor Action with Eucalyptus

Accion Vaporizante con Eucalypto

Cough Supressant/Anesthetic • Menthol 5.8mg

Suprima la tos/anestesico • Mentol 5.8 mg

Pull to Open

Tire Para Abrir

300 Lozenges

300 Pastillas

Individually Wrapped Cough Drops

Individualmento envuelto pastillas para la tos

Collect MediBucks

See inside flap for more details

109R MedikoffSFree109R MedikoffSFree

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
476973menthol 5.8 MG Oral LozengePSN15
476973menthol 5.8 MG Oral LozengeSCD15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-110-03Medique Sugar Free Medikoff Drops300 in 1 BOXLOZENGE30015
47682-110-05Medique Sugar Free Medikoff Drops5 in 1 BOXLOZENGE515

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
ISOMALTINACTIVE INGREDIENTS870P55O2W1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-11047682-110-03, 47682-110-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
EUCALYPTUS OIL2R04ONI662IACT
ISOMALTS870P55O2WIACT
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 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
12 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route
3 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route
3 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
12 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
12 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii+route
12 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii+route
3 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
12 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
12 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Sugar Free Medikoff DropsMENTHOLUnifirst First Aid Corporation92d13e19-4e7b-4565-970e-504abf02579a2025-09-08WarningsExact identifier
ndc (package): 47682-110-05
ndc (package): 47682-110-03
ndc (product): 47682-110
ndc11 (package): 47682011003
ndc11 (package): 47682011005
spl id: 3e4cc5df-a3ef-eb44-e063-6294a90a1b92
spl set id: 92d13e19-4e7b-4565-970e-504abf02579a

Reported adverse events (FAERS/openFDA)#

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