FDA.reportPublic FDA data

D82

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 02:31:12

Label at a glance#

ProductD82
Active ingredientACHILLEA MILLEFOLIUM, ARNICA MONTANA, HYPERICUM PERFORATUM, HORSE CHESTNUT, VISCUM ALBUM WHOLE
Label structure7 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0083-1

INDICATIONS & USAGE SECTION

INDICATIONS

OTC - PURPOSE SECTION

Stress, headache, sweating, rapid pulse, shortness of breath, dizziness, vision disturbances.

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTS

INACTIVE INGREDIENT SECTION

Millefolium 3x, Arnica montana 6x, Hypericum perforatum 3x, Aesculus hippocastanum 2x, Viscum album 3x, 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

  • 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 82

HOMEOPATHIC 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
58264-0083-12022-06-06C16284748780-19d75b9d0-1144-f424-e053-dadaa90a57ceD82
58264-0083-12020-01-31C16284748780-19d75b9d0-1144-f424-e053-dadaa90a57ceD82

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0083-1D8229.57 mL in 1 BOTTLE, DROPPERSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0083D82 (ACHILLEA MILLEFOLIUM, ARNICA MONTANA, HYPERICUM PERFORATUM, HORSE CHESTNUT, AND VISCUM ALBUM WHOLE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_2c24bb97-11be-450a-9cf9-5aadca1e8be1.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-008358264-0083-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
ARNICA MONTANAO80TY208ZWACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
VISCUM ALBUM WHOLEE6839Q6DO1ACTIB

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
D82ACHILLEA MILLEFOLIUM, ARNICA MONTANA, HYPERICUM PERFORATUM, HORSE CHESTNUT, AND VISCUM ALBUM WHOLEDNA Labs, Inc.2c24bb97-11be-450a-9cf9-5aadca1e8be12025-01-13WarningsExact identifier
ndc (package): 58264-0083-1
ndc (product): 58264-0083
ndc11 (package): 58264008301
spl id: 2b9ec82d-e5f9-ae16-e063-6394a90a5559
spl set id: 2c24bb97-11be-450a-9cf9-5aadca1e8be1

Reported adverse events (FAERS/openFDA)#

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