Benzodent

Manufacturer
Focus Consumer Healthcare, LLC
Effective date
2026-04-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:54:25

Label at a glance#

ProductBenzodent
Active ingredientBENZOCAINE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

OTC - PURPOSE SECTION

Pain reliever

INDICATIONS & USAGE SECTION

For the temporary relief of pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances or injury to mouth and gums.

DOSAGE & ADMINISTRATION SECTION

Adults and children12 years and over:

  • remove cap, break metal seal with cap point
  • apply directly to the gums or to the denture surface that comes in contact with the affected area of the gums
  • if you are using the dentures, wait a few minutes then reinsert dentures and you may use your regular denture adhesive with this product
  • use up to 4 times daily or as directed by a dentist or doctor
  • children under 12 years of age should be supervised in the use of this product

children under 12 years:consult a dentist or doctor

WARNINGS SECTION

Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried to the blood. This can occur even if you have used this product before. Stop use and seek immedicate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Alllergy alert:Do not use if you have a history of allergy to local anetsthetics such as procaine, butacaine, benzocaine, or other "caine: anesthetics. Localized allergic reactions may occur after prolonged or repeated use.

Do not use

OTC - DO NOT USE SECTION

  • for more than 7 consecutive days unless directed by a dentist of a doctor
  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not exceed recommended dosage

Stop use and ssk a doctor or dentist if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

INACTIVE INGREDIENT SECTION

cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BenzodentBenzodent

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
723562benzocaine 20 % Topical CreamPSN8
1112942Benzodent 20 % Topical CreamPSN8
1112942benzocaine 200 MG/ML Topical Cream [Benzodent]SBD8
723562benzocaine 200 MG/ML Topical CreamSCD8
723562benzocaine 20 % Topical CreamSY8
1112942Benzodent 20 % Oromucosal Topical CreamSY8
1112942Benzodent 200 MG/ML Topical CreamSY8

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71687-1053-12025-04-14C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent
71687-1053-22025-04-14C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent
71687-1053-12025-01-30C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent
71687-1053-22025-01-30C16284748780-12cef2736-a33e-d83d-e063-dadaa90ab31fBenzodent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71687-1053-1Benzodent7 g in 1 TUBECREAM78
71687-1053-1Benzodent1 in 1 CARTONCREAM18
71687-1053-2Benzodent28 g in 1 TUBECREAM288
71687-1053-2Benzodent1 in 1 CARTONCREAM18

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71687-105371687-1053-1, 71687-1053-2

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

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
BenzodentBENZOCAINEFocus Consumer Healthcare, LLC5fdcb871-d387-6352-e053-2991aa0a09da2026-04-20WarningsExact identifier
ndc (package): 71687-1053-2
ndc (package): 71687-1053-1
ndc (product): 71687-1053
ndc11 (package): 71687105301
ndc11 (package): 71687105302
spl id: 4fe8bad9-af0f-ad56-e063-6394a90a6e12
spl set id: 5fdcb871-d387-6352-e053-2991aa0a09da

Reported adverse events (FAERS/openFDA)#

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