DRUG FACTS:

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:29

Label at a glance#

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

Indications and uses

May temporarily relieve symptoms associated with dental procedures, such as: pain and minor swelling in the mouth or on the gums.** ** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a 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) Argentum Metallicum 12X 7.67%, Aurum Metallicum 12X 7.67%, Calcarea Fluorica 12X 7.67%, Calcarea Phosphorica 12X 7.67%, Hekla Lava 12X 7.67%, Hydrofluoricum Acidum 12X 7.67%, Iodium 12X 7.67%, Mercurius Solubilis 12X 7.67%, Niccolum Metallicum 12X 7.67%, Phytolacca Decandra 6X 7.67%, Platinum Metallicum 16X 7.67%, Silicea 12X 7.67%, Zincum Metallicum 12X 7.67%, Allium Sativum 3X 0.10%, Berberis Vulgaris 3X 0.10%, Fucus Vesiculosus 3X 0.10%.

PURPOSES:

OTC - PURPOSE SECTION

Argentum Metallicum – bruised pains**, Aurum Metallicum – foul breath**, Calcarea Fluorica – sensitive teeth**, Calcarea Phosphorica – bitter taste**, Hekla Lava – toothache**, Hydrofluoricum Acidum – sore mouth**, Iodium – sweetish taste**, Mercurius Solubilis – metallic taste**, Niccolum Metallicum – stiff tongue**, Phytolacca Decandra – lymphatic congestion**, Platinum Metallicum – tongue pain**, Silicea - dry mouth**, Zincum Metallicum – bleeding gums**, Allium Sativum – swollen gums**, Berberis Vulgaris – thick saliva**, Fucus Vesiculosus – neck swelling**.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

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

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

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 7 days.

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

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. 

• Consult a physician for use in children under 12 years of age.

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363113701777GTIN-13: 0363113701777
EAN-13: 0363113701777
GTIN-12: 363113701777
UPC-A: 363113701777
GTIN storage (14 digits): 00363113701777
ENRG93 Dentastat 8-8-24.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0661-12024-10-24C16284748780-11030e365-6721-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0661-12024-01-30C16284748780-11030e365-6721-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0661-1Dentastat30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-066144911-0661-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
ndc (package): 44911-0661-1
ndc (product): 44911-0661
ndc11 (package): 44911066101
spl id: 58c571c8-1ee3-4fa3-ae53-63e65d8bd9a9
spl set id: 12786efd-df42-4321-bfdf-88f542d387bb

Reported adverse events (FAERS/openFDA)#

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