SPL UNCLASSIFIED SECTION
Drug Facts
Drug Facts
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Oral antiseptic
Oral pain reliever
Oral astringent
temporary relief of pain due to toothache * to help protect against infection of minor oral irritation
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
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
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
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
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
ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
DISTRIBUTED BY:
PUBLIX SUPER MARKETS, 3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
PUBLIX SUPER MARKETS, INC
4X MEDICATED GEL
TOOTHACHE & GUM PAIN RELIEF
Compare to the active ingredients in Orajel
4X medicated for toothache & Gum gel*
NET WT 0.25OZ (7 g)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2369638 | benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral Gel | PSN | 6 |
| 2369638 | benzalkonium chloride 0.0013 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel | SCD | 6 |
| 2369638 | benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral Gel | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 56062-312-22 | 4x Medicated Toothache and Gum Gel | 7 g in 1 TUBE | GEL, DENTIFRICE | 7 | 6 | |
| 56062-312-22 | 4x Medicated Toothache and Gum Gel | 1 in 1 CARTON | GEL, DENTIFRICE | 1 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 56062-312 | 56062-312-22 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| SORBIC ACID | X045WJ989B | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-08-12 | full-release | 2026-06-01 01:10:01 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4x Medicated Toothache and Gum Gel | BENZOCAINE | Publix Super Markets INC | 16eb9d15-dba3-36e6-e063-6394a90ab859 | 2026-01-08 | Warnings | 56062-312-22 56062-312 56062031222 47e5dd07-fa98-97e1-e063-6394a90ae6a6 16eb9d15-dba3-36e6-e063-6394a90ab859 |
Adverse event summaries are temporarily unavailable. Other product information remains available.