FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:38:37

Label at a glance#

ProductDentaforce
Active ingredientANTIMONY TRISULFIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, MERCURIUS SOLUBILIS, LEAD, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, HYDROFLUORIC ACID
Label structure9 sections

Indications and uses

For temporary relief of gum, dentition, and tooth pain.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Antimonium Crudum 12X, Belladonna 12X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Hekla Lava 12X, Hydrofluoricum Acidum 30X, Mercurius Solubilis 12X, Plumbum Metallicum 12X, Sepia 12X, Silicea 12X.

PURPOSE:

OTC - PURPOSE SECTION

Antimonium Crudum - salivation,** Belladonna - fever,** Calcarea Carbonica - headache,** Calcarea Fluorica – tooth support,** Calcarea Phosphorica - toothache,** Hekla Lava – jaw pain,** Hydrofluoricum Acidum - swelling,** Mercurius Solubilis – bad breath,** Plumbum Metallicum - sensitivity,** Sepia – dental pain,** Silicea – tooth support**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of gum, dentition, and tooth pain.**

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

WARNINGS:

WARNINGS SECTION

​If pregnant or breast-feeding, ​ask a health care 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

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​BioActive Homeopathic

​DENTAFORCE

HOMEOPATHIC

​1 fl. oz. (30 mL)

DENTAFORCEDENTAFORCE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130211184341845GTIN-13: 0211184341845
EAN-13: 0211184341845
GTIN-12: 211184341845
UPC-A: 211184341845
GTIN storage (14 digits): 00211184341845		BANI0099 Dentaforce 03-10-26.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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0093-1Dentaforce30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38U1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
HEKLA LAVAACTIVE INGREDIENTC21158IIRK1
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ1
LEADACTIVE INGREDIENT2P299V784P1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z281
ANTIMONY TRISULFIDEACTIVE MOIETYF79059A38U1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
HEKLA LAVAACTIVE MOIETYC21158IIRK1
LEADACTIVE MOIETY2P299V784P1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-009343857-0093-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANTIMONY TRISULFIDEF79059A38UACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
HEKLA LAVAC21158IIRKACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
LEAD2P299V784PACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIM
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
ndc (package): 43857-0093-1
ndc (product): 43857-0093
ndc11 (package): 43857009301
spl id: 1adc1341-3133-4e89-8587-88c139d4308f
spl set id: 82321547-e04a-42ff-aa39-6a192638e5a2

Reported adverse events (FAERS/openFDA)#

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