FDA.reportPublic FDA data

Toothache and Gum Relief

Manufacturer
CVS Pharmacy | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:51:54

Label at a glance#

ProductToothache and Gum Relief
Active ingredientBENZOCAINE, MENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzocaine 20%

Menthol 0.1%

OTC - PURPOSE SECTION

Purpose

Oral pain reliever

Oral pain reliever

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of pain due to

  • canker sores
  • minor injury of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures

WARNINGS SECTION

Warnings

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 in blood. This can occur even if you have used this product before. Stop use and seek immediate 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

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor
  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use if package has been opened
  • adults and children 2 years of age and older: using applicator tip, apply to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children 12 years of age should be supervised in the use of this product
  • children under 2 years of age: do not use

OTHER SAFETY INFORMATION

Other information This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol, flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT: Carton is sealed for your protection.

Retain carton for complete product information.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP-CVS

Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health™

SEVERE PAIN RELIEF

Toothache & Gum Relief Liquid

ORAL PAIN RELIEVER

DOUBLE MEDICATED​

  • 20% BENZOCAINE to relieve oral pain
  • MENTHOL to soothe

0.5 FL OZ (14.7 mL)

CVS_SeverePain_Liquid_Ctn_F8015375CVS_SeverePain_Liquid_Ctn_F8015375

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2110600benzocaine 20 % / menthol 0.1 % Mucous Membrane Topical SolutionPSN7
2110600benzocaine 200 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCD7

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-353-29Toothache and Gum Relief14.7 mL in 1 BOTTLE, WITH APPLICATORLIQUID14.77
69842-353-29Toothache and Gum Relief1 in 1 CARTONLIQUID17

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
69842-35369842-353-29

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-01-20full-release2026-06-01 00:53:14

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
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
ndc (package): 69842-353-29
ndc (product): 69842-353
ndc11 (package): 69842035329
spl id: 47e5f657-c064-b740-e063-6394a90a114e
spl set id: 814ec7bf-f825-1095-e053-2a91aa0aee59

Reported adverse events (FAERS/openFDA)#

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