4x Medicated Toothache and Gum Gel

Manufacturer
Publix Super Markets INC | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:51:33

Label at a glance#

Product4x Medicated Toothache and Gum Gel
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, ZINC CHLORIDE, MENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

OTC - PURPOSE SECTION

Oral antiseptic

Oral pain reliever

Oral astringent

INDICATIONS & USAGE SECTION

temporary relief of pain due to toothache * to help protect against infection of minor oral irritation

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 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 lightheadness

fatique or lack of energy

Alergy 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 directed 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 or allergic reaction, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

cut open tip of tube on score mark

adults and children 2 years of age and older: apply a small amount of product 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 between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product

children under 2 years of age: do not use

do not use if tip is cut prior to opening * 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 *this formula will stay in place for extended duration of relief *avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

PUBLIX SUPER MARKETS, 3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PUBLIX SUPER MARKETS, INC

4X MEDICATED GEL

TOOTHACHE & GUM PAIN RELIEF

  • 20% Benzocaine to relieve oral pain
  • Kills harmful bacteria
  • Astringent to help prevent infection
  • Cools gum & relieves irritation

Compare to the active ingredients in Orajel

4X medicated for toothache & Gum gel*

NET WT 0.25OZ (7 g)

Publix 4X Medicated Toothache & Gum GelPublix 4X Medicated Toothache & Gum Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelPSN6
2369638benzalkonium chloride 0.0013 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD6
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-312-224x Medicated Toothache and Gum Gel7 g in 1 TUBEGEL, DENTIFRICE76
56062-312-224x Medicated Toothache and Gum Gel1 in 1 CARTONGEL, DENTIFRICE16

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56062-31256062-312-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-08-12full-release2026-06-01 01:10:01

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
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
ndc (package): 56062-312-22
ndc (product): 56062-312
ndc11 (package): 56062031222
spl id: 47e5dd07-fa98-97e1-e063-6394a90ae6a6
spl set id: 16eb9d15-dba3-36e6-e063-6394a90ab859

Reported adverse events (FAERS/openFDA)#

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