Dentastat

Manufacturer: Apotheca Company
Effective date: 2022-04-06
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 22:04:08

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, PLATINUM, SILICON DIOXIDE, ZINC

Label structure9 sections

Contacts and useful links#

PhoneLabel contact800-869-8078

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: Allium sativum 3X, Berberis vulgaris 3X, Fucus vesiculosus 3X, Phytolacca decandra 3X, Argentum metallicum 12X, Aurum metallicum 12X, Calcarea fluorica 12X, Calcarea phosphorica 12X, Iodium 12X, Mercurius solubilis 12X, Niccolum metallicum 12X, Platinum metallicum 12X, Silicea 12X, Zincum metallicum 12X.

OTC - PURPOSE SECTION

INDICATIONS: For temporary relief of pain and minor inflammation in the mouth, or on the gums following dental procedures.

WARNINGS SECTION

WARNINGS: 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.

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.

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

INDICATIONS: For temporary relief of pain and minor inflammation in the mouth, or on the gums following dental procedures.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol

OTC - QUESTIONS SECTION

Dist. By:

Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

DENTASTAT

Homeopathic Remedy

1 fl. oz. (30 ml)

Dentastat

Dentastat

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57520-0435-1	2022-04-07	C162847	48780-1	9d75b9d0-7c6c-f424-e053-dadaa90a57ce	Dentastat
57520-0435-1	2020-01-31	C162847	48780-1	9d75b9d0-7c6c-f424-e053-dadaa90a57ce	Dentastat

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BERBERIS VULGARIS ROOT BARK	ACTIVE INGREDIENT	1TH8Q20J0U	1
CALCIUM FLUORIDE	ACTIVE INGREDIENT	O3B55K4YKI	1
FUCUS VESICULOSUS	ACTIVE INGREDIENT	535G2ABX9M	1
GARLIC	ACTIVE INGREDIENT	V1V998DC17	1
GOLD	ACTIVE INGREDIENT	79Y1949PYO	1
IODINE	ACTIVE INGREDIENT	9679TC07X4	1
MERCURIUS SOLUBILIS	ACTIVE INGREDIENT	324Y4038G2	1
NICKEL	ACTIVE INGREDIENT	7OV03QG267	1
PHYTOLACCA AMERICANA ROOT	ACTIVE INGREDIENT	11E6VI8VEG	1
PLATINUM	ACTIVE INGREDIENT	49DFR088MY	1
SILICON DIOXIDE	ACTIVE INGREDIENT	ETJ7Z6XBU4	1
SILVER	ACTIVE INGREDIENT	3M4G523W1G	1
TRIBASIC CALCIUM PHOSPHATE	ACTIVE INGREDIENT	91D9GV0Z28	1
ZINC	ACTIVE INGREDIENT	J41CSQ7QDS	1
BERBERIS VULGARIS ROOT BARK	ACTIVE MOIETY	1TH8Q20J0U	1
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	1
CALCIUM FLUORIDE	ACTIVE MOIETY	O3B55K4YKI	1
FUCUS VESICULOSUS	ACTIVE MOIETY	535G2ABX9M	1
GARLIC	ACTIVE MOIETY	V1V998DC17	1
GOLD	ACTIVE MOIETY	79Y1949PYO	1
IODINE	ACTIVE MOIETY	9679TC07X4	1
MERCURIUS SOLUBILIS	ACTIVE MOIETY	324Y4038G2	1
NICKEL	ACTIVE MOIETY	7OV03QG267	1
PHYTOLACCA AMERICANA ROOT	ACTIVE MOIETY	11E6VI8VEG	1
PLATINUM	ACTIVE MOIETY	49DFR088MY	1
SILICON DIOXIDE	ACTIVE MOIETY	ETJ7Z6XBU4	1
SILVER	ACTIVE MOIETY	3M4G523W1G	1
ZINC	ACTIVE MOIETY	J41CSQ7QDS	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Dentastat
Allium sativum, Berberis vulgaris, Fucus vesiculosus, Phytolacca decandra, Argentum metallicum, Aurum metallicum, Calcarea fluorica, Calcarea phosphorica, Iodium, Mercurius solubilis, Niccolum metallicum, Platinum metallicum, Silicea, Zincum metallicum
GARLIC
BERBERIS VULGARIS ROOT BARK
FUCUS VESICULOSUS
PHYTOLACCA AMERICANA ROOT
SILVER
GOLD
CALCIUM FLUORIDE
FLUORIDE ION
TRIBASIC CALCIUM PHOSPHATE
CALCIUM CATION
IODINE
MERCURIUS SOLUBILIS
NICKEL
PLATINUM
SILICON DIOXIDE
ZINC
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57520-0435	57520-0435-1

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
GARLIC	V1V998DC17	ACTIB
BERBERIS VULGARIS ROOT BARK	1TH8Q20J0U	ACTIB
FUCUS VESICULOSUS	535G2ABX9M	ACTIB
PHYTOLACCA AMERICANA ROOT	11E6VI8VEG	ACTIB
SILVER	3M4G523W1G	ACTIB
GOLD	79Y1949PYO	ACTIB
CALCIUM FLUORIDE	O3B55K4YKI	ACTIB
TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	ACTIM
IODINE	9679TC07X4	ACTIB
MERCURIUS SOLUBILIS	324Y4038G2	ACTIB
NICKEL	7OV03QG267	ACTIB
PLATINUM	49DFR088MY	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	ACTIB
ZINC	J41CSQ7QDS	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
16995a8d-c0e7-4502-b7b8-b5cba7048e84			3ec9b19e-a175-4ba5-b551-d1921f91dc54	2022-04-06	Warnings	Exact identifier spl id: 16995a8d-c0e7-4502-b7b8-b5cba7048e84 spl set id: 3ec9b19e-a175-4ba5-b551-d1921f91dc54

Reported adverse events (FAERS/openFDA)#

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