FDA.reportPublic FDA data

Dolodent

Manufacturer
Pharmadel LLC
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:19:28

Label at a glance#

ProductDolodent Max Strength
Active ingredientARNICA MONTANA, CHAMOMILE, FERULA ASSA-FOETIDA RESIN, HYPERICUM PERFORATUM, HEKLA LAVA
Label structure9 sections

Indications and uses

For the temporary relief of oral pain due to minor irritation of the mouth and gums.

Dosage and administration

shake well before use adults and children 12 years of age and over: add 2-3 drops to a small piece of cotton or gauze apply to the affected area and allow in place for at least 1 minute and spit out repeat as needed children under 12 years of age: consult a dentist or doctor

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients**(HPUS) Purposes*
Arnica montana 30XPain in the tooth, with inflammation
Asa foetida 6XCavity pain
Chamomilla vulgaris 30Irritation, toothache, sore gums
Hekla lava 30XTooth sensitive to pressure, with swollen gums
Hypericum perforatum 30XSharp shooting pain, due to toothache

The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

Uses*

INDICATIONS & USAGE SECTION

For the temporary relief of oral pain due to minor irritation of the mouth and gums.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • this product for more than 7 days
  • if you are allergic to any ingredients in this product

Stop use and ask your doctor or dentist if

OTC - STOP USE SECTION

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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

seek professional advice before taking this product.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use

adults and children 12 years of age and over:

  • add 2-3 drops to a small piece of cotton or gauze
  • apply to the affected area and allow in place for at least 1 minute and spit out
  • repeat as needed

children under 12 years of age: consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

clove oil, polysorbate 20, sucrose, water

Question & comments?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com

Distributed by:/ Distribuido por:

SPL UNCLASSIFIED SECTION

PHARMADEL
New Castle, DE 19720
+ 1-866-359-3478
www.pharmadel.com

Made in India

Homeopathic Statements

SPL UNCLASSIFIED SECTION

*These “ USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based on traditional homeopathic practices.

**C, K, CK and X are homeopathic dilutions.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DD PDP HWDD PDP HW

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-400DOLODENT MAX STRENGTH (ARNICA MONTANA, ASAFOEDIDA, CHAMOMILLA, HECLA LAVA, HYPERICUM) LIQUID [PHARMADEL LLC]3Unmatched20231201_042748e2-e755-570e-e063-6394a90a150a.zip

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
55758-40055758-400-15

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
PROPOLIS WAX6Y8XYV2NOFIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWACTIB
CHAMOMILEFGL3685T2XACTIB
CLOVE OIL578389D6D0IACT
FERULA ASSA-FOETIDA RESINW9FZA51AS1ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
POLYSORBATE 207T1F30V5YHIACT
HEKLA LAVAC21158IIRKACTIB
SUCROSEC151H8M554IACT

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
364c427f-b0d0-a677-e063-6294a90a0d40042748e2-e755-570e-e063-6394a90a150a2025-05-29WarningsExact identifier
spl set id: 042748e2-e755-570e-e063-6394a90a150a

Reported adverse events (FAERS/openFDA)#

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