FDA.reportPublic FDA data

Dolodent

Manufacturer
Pharmadel LLC | JMM Services
Effective date
2019-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:01:32

Label at a glance#

ProductDolodent
Active ingredientCHAMOMILE, FERULA ASSA-FOETIDA RESIN, HYPERICUM PERFORATUM, HEKLA LAVA, ARNICA MONTANA
Label structure7 sections

Indications and uses

Temporarily relieves toothaches These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Dosage and administration

Shake well before use. Soak a small piece of cotton or gauze and apply to painful area. Repeat as needed.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients HPUSPurpose
Arnica Montana 30x..........Pain in the teeth, with swelling of the cheeks
Asafoedida 6x.............................Bone pain
Chamomilla vulg. 30x...............Toothache
Hecla lava 30x................T oothache sensitive to pressure, with swelling of jaws
Hypericum perf. 30x.....................Sharp shooting pain Neuralgia

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves toothaches

These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Warnings

WARNINGS SECTION

Ask a doctor or dentist if

OTC - ASK DOCTOR SECTION

•Pregnant or breastfeeding
•Under 12 years of age
•Symptoms persist more than 2 days or reoccur
•You are allergic to any of the ingredients

Keep this and all medications out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use

OTC - DO NOT USE SECTION

if tamper neck band is broken or missing.

Question or comments?

OTC - QUESTIONS SECTION

1-866-359-3478 (M-F) 9AM to 5PM Eastern Time

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Soak a small piece of cotton or gauze and apply to painful area. Repeat as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin USP, Ethanol USP 20%, Clove oil, Propolis, Polysorbate 20

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DoloDent

  • Toothache/Dolor de muela
  • Sore gums/Dolor de encias
  • Braces irritation/ Irritacion de frenos

DoloDent

MAXIMUM STRENGTH

Instant Relief

  • Toothache
  • Sore gums
  • Braces irritation

DoloDent

Extra Fuerte

Alivio Instantaneo

  • Dolor de muela
  • Dolor de encias
  • Irritacion de frenos

GOTAS BUCALES

HOMEOPATICAS

Contenido Neto: 15mL

DoloDentDoloDent

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-02955758-029-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILEFGL3685T2XACTIB
CLOVE OIL578389D6D0IACT
FERULA ASSA-FOETIDA RESINW9FZA51AS1ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
GLYCERINPDC6A3C0OXIACT
PROPOLIS WAX6Y8XYV2NOFIACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MIACT
HEKLA LAVAC21158IIRKACTIB
ARNICA MONTANAO80TY208ZWACTIB

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
d08af150-0388-afc7-e053-2a95a90adecd973d092d-88ff-69f4-e053-2995a90a05742021-11-11WarningsExact identifier
spl set id: 973d092d-88ff-69f4-e053-2995a90a0574

Reported adverse events (FAERS/openFDA)#

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