FDA.reportPublic FDA data

D3

Manufacturer
DNA Labs, Inc.
Effective date
2018-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:12

Label at a glance#

ProductD3
Active ingredientDIGITALIS PURPUREA WHOLE, STROPHANTHUS HISPIDUS WHOLE, CRATAEGUS MEXICANA WHOLE, SELENICEREUS GRANDIFLORUS WHOLE, KALMIA LATIFOLIA WHOLE, ARSENIC TRIOXIDE, PHOSPHORUS, DRIMIA MARITIMA WHOLE, SPIGELIA ANTHELMIA, POTASSIUM CARBONATE
Label structure9 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0003-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Heart insufficiencies.

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTS

INACTIVE INGREDIENT SECTION

Digitalis purpurea 4x, Strophanthus 6x, Crataegus oxyacantha 1x, Cactus grandiflorus 2x, Kalmia latifolia 3x, Arsenicum album 5x, Phosphorus 5x, Scilla maritima 4x, Spigelia anthelmia 3x, Kalium carbonicum 4x, 20% alcohol in purified water.

RX CAUTION

SPL UNCLASSIFIED SECTION

Federal law prohibits dispensing without a prescription.

SUGGESTED DOSAGE

DOSAGE & ADMINISTRATION SECTION

One dropper full under the tongue two times daily. In acute conditions 5-10 drops under the tongue every 20-30 minutes.

STORAGE AND HANDLING SECTION

SHAKE WELL

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

  • Use only if cap seal is unbroken.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • As with drugs if you are pregnant or nursing a baby seek professional advice before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all medication out of the reach of children.

SPL UNCLASSIFIED SECTION

To be used according to standard homeopathic indications.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DYNAMIC
NUTRITIONAL
ASSOCIATES, INC.

D 3

HOMEOPATHIC FORMULA

1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0003-12020-01-31C16284748780-19d75b9d0-957a-f424-e053-dadaa90a57ceD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0003-1D329.57 mL in 1 BOTTLE, GLASSSOLUTION29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0003D3 (DIGITALIS PURPUREA WHOLE, STROPHANTHUS HISPIDUS WHOLE, CRATAEGUS MEXICANA WHOLE, SELENICEREUS GRANDIFLORUS WHOLE, KALMIA LATIFOLIA WHOLE, ARSENIC TRIOXIDE, PHOSPHORUS, DRIMIA MARITIMA WHOLE, SPIGELIA ANTHELMIA, AND POTASSIUM CARBONATE) SOLUTION [DNA LABS, INC.]1Legacy NDC, 1 package rows20180202_3cde4a8f-806a-4b23-8d49-b21150654f6d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-000358264-0003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIGITALIS PURPUREA WHOLEUD4O8TY7RWACTIM
STROPHANTHUS HISPIDUS WHOLEW753F6AWFHACTIB
CRATAEGUS MEXICANA WHOLE09IF4Y848SACTIB
SELENICEREUS GRANDIFLORUS WHOLEX8H7HS7MRMACTIB
KALMIA LATIFOLIA WHOLEP1SWF7DK1YACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
PHOSPHORUS27YLU75U4WACTIB
DRIMIA MARITIMA WHOLEUNM4C1735ZACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
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
476d8bed-d4bd-4695-ba0f-8fd80cd1af0d3cde4a8f-806a-4b23-8d49-b21150654f6d2018-02-01WarningsExact identifier
spl id: 476d8bed-d4bd-4695-ba0f-8fd80cd1af0d
spl set id: 3cde4a8f-806a-4b23-8d49-b21150654f6d

Reported adverse events (FAERS/openFDA)#

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