Dentastat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2022-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:51:54

Label at a glance#

ProductDentastat
Active ingredientGARLIC, BERBERIS VULGARIS ROOT BARK, FUCUS VESICULOSUS, PHYTOLACCA AMERICANA ROOT, SILVER, GOLD, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, IODINE, MERCURIUS SOLUBILIS, NICKEL, SILICON DIOXIDE, ZINC, PLATINUM
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 9.06% of Argentum Metallicum 12X, Aurum Metallicum 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Iodium 12X, Mercurius Solubilis 12X, Niccolum Metallicum 12X, Phytolacca Decandra 6X, Platinum Metallicum 16X, Silicea 12X, Zincum Metallicum 12X; 0.10% of Allium Sativum 3X, Berberis Vulgaris 3X, Fucus Vesiculosus 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with dental procedures, such as pain and minor inflammation in the mouth or on the gums.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with dental procedures, such as pain and minor inflammation in the mouth or on the gums.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DENTASTAT

1 fl. oz. (30 ml)

DentastatDentastat

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0555-12022-10-11C16284748780-1d6a99b39-c701-a426-e053-dadaa90af4c2Drug Facts:
44911-0555-12022-01-28C16284748780-1d6a99b39-c701-a426-e053-dadaa90af4c2Drug Facts:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0555DENTASTAT (ALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUM) LIQUID [ENERGIQUE, INC.]2Legacy NDC20221012_acfadaf0-60e4-4268-8b5b-8d26fdd871d7.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-055544911-0555-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
cd186625-adaf-4614-abb3-6d10ddfd1956acfadaf0-60e4-4268-8b5b-8d26fdd871d72022-10-11WarningsExact identifier
spl id: cd186625-adaf-4614-abb3-6d10ddfd1956
spl set id: acfadaf0-60e4-4268-8b5b-8d26fdd871d7

Reported adverse events (FAERS/openFDA)#

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