Home NDC 44911-0661 Dentastat
Product NDC 44911-0661
11-digit product format 449110661
Labeler code 44911
Product ID 44911-0661_58c571c8-1ee3-4fa3-ae53-63e65d8bd9a9
Type HUMAN OTC DRUG
Nonproprietary name Allium 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 Metallicum
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-10-06
Marketing end 2029-08-27
Substance BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; FUCUS VESICULOSUS; GARLIC; GOLD; HEKLA LAVA; HYDROFLUORIC ACID; IODINE; MERCURIUS SOLUBILIS; NICKEL; PHYTOLACCA AMERICANA ROOT; PLATINUM; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; ZINC
Active strength 3; 12; 3; 3; 12; 12; 12; 12; 12; 12; 6; 16; 12; 12; 12; 12 [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; [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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 44911-0661-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0661-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0661-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0661-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0661-1 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Dentastat Active Ingredients# Ingredient, Strength table Ingredient Strength GARLIC 3 [hp_X]/mL BERBERIS VULGARIS ROOT BARK 12 [hp_X]/mL FUCUS VESICULOSUS 3 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL SILVER 12 [hp_X]/mL GOLD 12 [hp_X]/mL CALCIUM FLUORIDE 12 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/mL HEKLA LAVA 12 [hp_X]/mL HYDROFLUORIC ACID 12 [hp_X]/mL IODINE 6 [hp_X]/mL MERCURIUS SOLUBILIS 16 [hp_X]/mL NICKEL 12 [hp_X]/mL SILICON DIOXIDE 12 [hp_X]/mL ZINC 12 [hp_X]/mL PLATINUM 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 16 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0661-1 Dentastat 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0661 DENTASTAT (ALLIUM 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 METALLICUM) LIQUID [ENERGIQUE, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241027_12786efd-df42-4321-bfdf-88f542d387bb.zip
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 Dentastat ALLIUM 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 METALLICUM Energique, Inc. 12786efd-df42-4321-bfdf-88f542d387bb 2026-05-06 Warnings Exact identifier ndc (product): 44911-0661
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0661-1 44911066101 30 mL in 1 BOTTLE, DROPPER (44911-0661-1) 30 ml 2022-10-06 2029-08-27 No No Current