Sore Throat Logenzes

Manufacturer
Major Pharmaceuticals | Bestco | Bestco, Inc.
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:47:03

Label at a glance#

ProductSore Throat Logenzes Sore Throat
Active ingredientBENZOCAINE, MENTHOL
Label structure10 sections

Indications and uses

temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores

Dosage and administration

adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: ask a doctor

Storage and handling

tamper evident packaging: Do not use if outer box or blister is open or damaged.  store at room temperature protect contents from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each lozenge)Purpose
 Benzocaine 15 mg Oral pain reliever
 Menthol 3.6 mg Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

  • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning

SPL UNCLASSIFIED SECTION

  • 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.

OTC - DO NOT USE SECTION

Do not usein a child under 5 years of age.

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • tamper evident packaging: Do not use if outer box or blister is open or damaged. 
  • store at room temperature
  • protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-616-2471

SPL UNCLASSIFIED SECTION

Dist. by:
Major Pharmaceuticals
Livonia, MI 48150  USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major Cherry Benzocaine 18ct LozengesMajor Cherry Benzocaine 18ct Lozenges

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengePSN5
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengeSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130309046255499GTIN-13: 0309046255499
EAN-13: 0309046255499
GTIN-12: 309046255499
UPC-A: 309046255499
GTIN storage (14 digits): 00309046255499
60002649 Major Cherry Benzocaine 18ct_Page_1.jpg
Data codeData Matrix6000264960002649 Major Cherry Benzocaine 18ct_Page_1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-6255-492023-11-09C16284748780-1d6a99b39-9f14-a426-e053-dadaa90af4c2Cēpacol ® SORE THROAT
0904-6255-492022-01-28C16284748780-1d6a99b39-9f14-a426-e053-dadaa90af4c2Cēpacol ® SORE THROAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6255-49Sore Throat LogenzesSore Throat18 in 1 BLISTER PACKLOZENGE185
0904-6255-49Sore Throat LogenzesSore Throat18 in 1 CARTONLOZENGE185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6255-49EA - Each0904-6255a2eb59a3-971e-4b7e-9167-67437d05552812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
BENZOCAINEACTIVE MOIETYU3RSY48JW51
MENTHOLACTIVE MOIETYL7T10EIP3A1
ALLYL SUCROSEINACTIVE INGREDIENTVI3D59RW0U1
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6N1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918C1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-62550904-6255-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 2 · 110 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET / ORAL13.5 mgExact identifier — unii+route
8 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION / ORAL2500 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTROCHE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii+route
44 equally ranked IID candidates
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii+route
8 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii+route
44 equally ranked IID candidates
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii+route
8 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NCAPSULE, EXTENDED RELEASE / ORAL28.5 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET / ORAL14.07 mgExact identifier — unii+route
18 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NCAPSULE, EXTENDED RELEASE / ORAL28.5 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION / ORAL2500 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
44 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET, COATED / ORAL17 mgExact identifier — unii+route
18 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
44 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
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
ndc (package): 0904-6255-49
ndc (product): 0904-6255
ndc11 (package): 00904625549
spl id: 4b972e11-08d1-5afd-e063-6294a90a97f1
spl set id: 11416620-4892-44ba-9780-db27efff6743

Reported adverse events (FAERS/openFDA)#

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