DANDI HP

Product NDC
43406-0616
11-digit product format
434060616
Labeler code
43406
Product ID
43406-0616_1d24fc6c-f881-4a83-b30f-c6290e65cc8f
Type
HUMAN OTC DRUG
Nonproprietary name
Milk Thistle, Dysphania Ambrosioides, Bos Taurus Bile, Golden Seal, Potassium Tartrate HemiHydrate, Taraxacum Officinale, Iodine, Arsenic Trioxide, Oster SHell Calcium Carbonate, Crude, Lycopodium Clavatum Spore, Magnesium Chloride, Mercurius Solubilis, Sodium Sulfate, Strychnos Nux-Vomica Seed, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
Natural Creations, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-06-30
Substance
ARSENIC TRIOXIDE; BOS TAURUS BILE; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; MERCURIUS SOLUBILIS; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM TARTRATE HEMIHYDRATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE
Active strength
30; 8; 8; 8; 6; 30; 30; 30; 8; 30; 30; 8; 30; 30; 8 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DANDI HP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE30 [hp_C]/mL
BOS TAURUS BILE8 [hp_X]/mL
DYSPHANIA AMBROSIOIDES8 [hp_X]/mL
GOLDENSEAL8 [hp_X]/mL
IODINE6 [hp_C]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_C]/mL
MAGNESIUM CHLORIDE30 [hp_C]/mL
MERCURIUS SOLUBILIS30 [hp_C]/mL
MILK THISTLE8 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]/mL
PHOSPHORUS30 [hp_C]/mL
POTASSIUM TARTRATE HEMIHYDRATE8 [hp_X]/mL
SODIUM SULFATE30 [hp_C]/mL
STRYCHNOS NUX-VOMICA SEED30 [hp_C]/mL
TARAXACUM OFFICINALE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, ET3651ZLOU, 4H5RSU087I, ZW3Z11D0JV, 9679TC07X4, C88X29Y479, 02F3473H9O, 324Y4038G2, U946SH95EE, 2E32821G6I, 27YLU75U4W, GM5EY0N07D, 0YPR65R21J, 269XH13919, 39981FM375

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0616-12022-03-03C16284748780-1d6a99b39-ba31-a426-e053-dadaa90af4c2DANDI HP
43406-0616-12022-01-28C16284748780-1d6a99b39-ba31-a426-e053-dadaa90af4c2DANDI HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0616-1DANDI HP30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0616DANDI HP (MILK THISTLE, DYSPHANIA AMBROSIOIDES, BOS TAURUS BILE, GOLDEN SEAL, POTASSIUM TARTRATE HEMIHYDRATE, TARAXACUM OFFICINALE, IODINE, ARSENIC TRIOXIDE, OSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS) LIQUID [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20220304_44c7d388-6c40-47e2-9760-4e5075fc0e7b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43406-0616-14340606160130 mL in 1 BOTTLE, DROPPER (43406-0616-1) 30 ml2016-06-300000-00-00NoNoCurrent