FDA.reportPublic FDA data

D-58

Manufacturer
DNA Labs, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:25

Label at a glance#

ProductD-58
Active ingredientADONIS VERNALIS, CONVALLARIA MAJALIS, HELLEBORUS NIGER ROOT, DIGITALIS, CRATAEGUS LAEVIGATA FRUIT, DRIMIA MARITIMA BULB
Label structure9 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0058-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Muscular weakness of the heart, edema of the legs.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Adonis vernalis 2x, Convallaria majalis 2x, Helleborus niger 4x, Digitalis purpurea 4x, Crataegus oxyacantha 1x, Scilla maritima 4x

INACTIVE

INACTIVE INGREDIENT SECTION

20% alcohol in purified water.

Rx CAUTION

SPL UNCLASSIFIED SECTION

Federal law prohibits dispensing without a prescription.

SUGGESTED DOSAGE

DOSAGE & ADMINISTRATION SECTION

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

STORAGE AND HANDLING SECTION

SHAKE WELL

Warnings

WARNINGS SECTION

  • Use only if cap seal is unbroken.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breastfeeding, ask a healthcare professional before use.

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 58

HOMEOPATHIC
STRESS FORMULA

1 FL. OZ.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0058-12022-06-03C16284748780-19d75b9d0-aae3-f424-e053-dadaa90a57ceD-58
58264-0058-12020-01-31C16284748780-19d75b9d0-aae3-f424-e053-dadaa90a57ceD-58

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0058-1D-5829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0058D-58 (ADONIS VERNALIS, CONVALLARIA MAJALIS, HELLEBORUS NIGER ROOT, DIGITALIS, CRATAEGUS LAEVIGATA FRUIT, AND DRIMIA MARITIMA BULB) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_e73d5830-1f04-478b-9178-63dc104c4a9c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-005858264-0058-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ADONIS VERNALISDX3ZNI25WKACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
DIGITALISF1T8QT9U8BACTIB
CRATAEGUS LAEVIGATA FRUITD5RZ7MF1YFACTIB
DRIMIA MARITIMA BULB3629601H5DACTIB

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
D-58ADONIS VERNALIS, CONVALLARIA MAJALIS, HELLEBORUS NIGER ROOT, DIGITALIS, CRATAEGUS LAEVIGATA FRUIT, AND DRIMIA MARITIMA BULBDNA Labs, Inc.e73d5830-1f04-478b-9178-63dc104c4a9c2025-01-13WarningsExact identifier
ndc (package): 58264-0058-1
ndc (product): 58264-0058
ndc11 (package): 58264005801
spl id: 2b9ecbda-7106-d64a-e063-6294a90aac9e
spl set id: e73d5830-1f04-478b-9178-63dc104c4a9c

Reported adverse events (FAERS/openFDA)#

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