Dentastat

Product NDC
57520-0435
Requested package NDC
57520-0435-1
11-digit product format
575200435
Labeler code
57520
Product ID
57520-0435_16995a8d-c0e7-4502-b7b8-b5cba7048e84
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-05-21
Marketing end
2022-09-08
Substance
BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; FUCUS VESICULOSUS; GARLIC; GOLD; IODINE; MERCURIUS SOLUBILIS; NICKEL; PHYTOLACCA AMERICANA ROOT; PLATINUM; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; ZINC
Active strength
3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57520-043557520-0435-1DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0435-12022-04-07C16284748780-19d75b9d0-7c6c-f424-e053-dadaa90a57ceDentastat
57520-0435-12020-01-31C16284748780-19d75b9d0-7c6c-f424-e053-dadaa90a57ceDentastat

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0UDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKIDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
FUCUS VESICULOSUSACTIVE INGREDIENT535G2ABX9MDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
GARLICACTIVE INGREDIENTV1V998DC17DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
GOLDACTIVE INGREDIENT79Y1949PYODENTASTAT (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) LIQUID [APOTHECA COMPANY]1
IODINEACTIVE INGREDIENT9679TC07X4DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
NICKELACTIVE INGREDIENT7OV03QG267DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
PLATINUMACTIVE INGREDIENT49DFR088MYDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
SILVERACTIVE INGREDIENT3M4G523W1GDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z28DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
ZINCACTIVE INGREDIENTJ41CSQ7QDSDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0UDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
CALCIUM FLUORIDEACTIVE MOIETYO3B55K4YKIDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
FUCUS VESICULOSUSACTIVE MOIETY535G2ABX9MDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
GARLICACTIVE MOIETYV1V998DC17DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
GOLDACTIVE MOIETY79Y1949PYODENTASTAT (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) LIQUID [APOTHECA COMPANY]1
IODINEACTIVE MOIETY9679TC07X4DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
NICKELACTIVE MOIETY7OV03QG267DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
PLATINUMACTIVE MOIETY49DFR088MYDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4DENTASTAT (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) LIQUID [APOTHECA COMPANY]1
SILVERACTIVE MOIETY3M4G523W1GDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
ZINCACTIVE MOIETYJ41CSQ7QDSDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDENTASTAT (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) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RDENTASTAT (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) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0435-15752004350130 mL in 1 BOTTLE, DROPPER (57520-0435-1) 30 ml2010-05-212022-09-08NoNoCurrent