FDA.reportPublic FDA data

D-55

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 02:31:10

Label at a glance#

ProductD-55
Active ingredientCOMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0055-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Injuries of all types.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Symphytum officinale 6x, Arnica montana 3x, Calendula officinalis 3x, Echinacea angustifolia 3x, Hamamelis virginiana 4x, Belladonna 4x, Ruta graveolens 6x, Rhus toxicodendron 6x

INACTIVE

INACTIVE INGREDIENT SECTION

20% alcohol in purified water.

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 55

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
58264-0055-12022-06-03C16284748780-19d75b9d0-7e6d-f424-e053-dadaa90a57ceD-55
58264-0055-12020-01-31C16284748780-19d75b9d0-7e6d-f424-e053-dadaa90a57ceD-55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0055-1D-5529.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0055D-55 (COMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, AND TOXICODENDRON PUBESCENS LEAF) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_1a316983-a023-4174-9aef-9e268a5799c1.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-005558264-0055-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
COMFREY ROOTM9VVZ08EKQACTIB
ARNICA MONTANAO80TY208ZWACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB

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-55COMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.1a316983-a023-4174-9aef-9e268a5799c12025-01-13WarningsExact identifier
ndc (package): 58264-0055-1
ndc (product): 58264-0055
ndc11 (package): 58264005501
spl id: 2b9ec8dd-73b1-e366-e063-6394a90ae792
spl set id: 1a316983-a023-4174-9aef-9e268a5799c1

Reported adverse events (FAERS/openFDA)#

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