Label: DENTASTAT- allium sativum, berberis vulgaris, fucus vesiculosus, phytolacca decandra, argentum metallicum, aurum metallicum, calcarea fluorica, calcarea phosphorica, iodium, mercurius solubilis, niccolum metallicum, silicea, zincum metallicum, platinum metallicum liquid
- NDC Code(s): 44911-0555-1
- Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated October 11, 2022
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ACTIVE INGREDIENTS:
(in each drop): 9.06% of Argentum Metallicum 12X, Aurum Metallicum 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Iodium 12X, Mercurius Solubilis 12X, Niccolum Metallicum 12X, Phytolacca Decandra 6X, Platinum Metallicum 16X, Silicea 12X, Zincum Metallicum 12X; 0.10% of Allium Sativum 3X, Berberis Vulgaris 3X, Fucus Vesiculosus 3X.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
DENTASTAT
allium sativum, berberis vulgaris, fucus vesiculosus, phytolacca decandra, argentum metallicum, aurum metallicum, calcarea fluorica, calcarea phosphorica, iodium, mercurius solubilis, niccolum metallicum, silicea, zincum metallicum, platinum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0555 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 3 [hp_X] in 1 mL BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 3 [hp_X] in 1 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 3 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 6 [hp_X] in 1 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 12 [hp_X] in 1 mL GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 12 [hp_X] in 1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 12 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 12 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267) NICKEL 12 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] in 1 mL PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM 16 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0555-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/12/2020 08/25/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/12/2020 08/25/2025 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0555) , api manufacture(44911-0555) , label(44911-0555) , pack(44911-0555)