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

Additional Listing Data#

Finished product
Yes
Brand name base
Dentastat

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
CALCIUM FLUORIDE12 [hp_X]/mL
FUCUS VESICULOSUS3 [hp_X]/mL
GARLIC3 [hp_X]/mL
GOLD12 [hp_X]/mL
HEKLA LAVA12 [hp_X]/mL
HYDROFLUORIC ACID12 [hp_X]/mL
IODINE12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
NICKEL12 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/mL
PLATINUM16 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
SILVER12 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/mL
ZINC12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, O3B55K4YKI, 535G2ABX9M, V1V998DC17, 79Y1949PYO, C21158IIRK, RGL5YE86CZ, 9679TC07X4, 324Y4038G2, 7OV03QG267, 11E6VI8VEG, 49DFR088MY, ETJ7Z6XBU4, 3M4G523W1G, 91D9GV0Z28, J41CSQ7QDS

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0661DENTASTAT (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.]2Current NDC, Legacy NDC, 1 package rows20241027_12786efd-df42-4321-bfdf-88f542d387bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0661-14491106610130 mL in 1 BOTTLE, DROPPER (44911-0661-1) 30 ml2022-10-062029-08-27NoNoCurrent