FDA.reportPublic FDA data

DANDI HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:43

Label at a glance#

ProductDANDI HP
Active ingredientMILK THISTLE, DYSPHANIA AMBROSIOIDES, BOS TAURUS BILE, GOLDENSEAL, POTASSIUM TARTRATE HEMIHYDRATE, TARAXACUM OFFICINALE, IODINE, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Carduus Marianus 8X, Chenopodium Anthelminticum 8X, Fel Tauri 8X, Hydrastis Canadensis 8X, Kali Tartaricum 8X, Taraxacum Officinale 8X, Iodium 6C, Arsenicum Album 30C, Calcarea Carbonica 30C, Lycopodium Clavatum 30C, Magnesia Muriatica 30C, Mercurius Solubilis 30C, Natrum Sulphuricum 30C, Nux Vomica 30C, Phosphorus 30C.

OTC - PURPOSE SECTION

USES: Temporarily relieves vomiting, diarrhea, pain, and soreness.**

INDICATIONS & USAGE SECTION

USES: Temporarily relieves vomiting, diarrhea, pain, and soreness.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care  professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopahic Pharmacopeia of the United States.

**Claims beased on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0616-1

DANDI HP

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730004543GTIN-13: 0877730004543
EAN-13: 0877730004543
GTIN-12: 877730004543
UPC-A: 877730004543
GTIN storage (14 digits): 00877730004543		DANDI HP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
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63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
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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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-061643406-0616-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MILK THISTLEU946SH95EEACTIB
DYSPHANIA AMBROSIOIDES4H5RSU087IACTIB
BOS TAURUS BILEET3651ZLOUACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM TARTRATE HEMIHYDRATEGM5EY0N07DACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
IODINE9679TC07X4ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIM
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DANDI HPMILK 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, PHOSPHORUSNatural Creations, Inc.44c7d388-6c40-47e2-9760-4e5075fc0e7b2025-12-08WarningsExact identifier
ndc (package): 43406-0616-1
ndc (product): 43406-0616
ndc11 (package): 43406061601
spl id: 1d24fc6c-f881-4a83-b30f-c6290e65cc8f
spl set id: 44c7d388-6c40-47e2-9760-4e5075fc0e7b

Reported adverse events (FAERS/openFDA)#

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