FDA.reportPublic FDA data

D81

Manufacturer
DNA Labs, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:31:13

Label at a glance#

ProductD81
Active ingredientPASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, LARREA DIVARICATA WHOLE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0082-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Supports a healthy lymphactic system.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Xanthoxylum Ø, Sarsaparilla Ø, Phytolacca Ø, Stillingia Ø, Trifolium pratense Ø, Arctium lappa Ø, Amygdalus Ø, Cascara sagrada Ø, Berberis vulgaris Ø, Glycyrrhiza glabra Ø, Larrea divaricata Ø, 54% alcohol in purified water.

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-81

HOMEOPATHIC FORMULA

1 FL. OZ.

D-81D-81

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0082-12022-06-06C16284748780-19d75b9d0-3ca0-f424-e053-dadaa90a57ceD-81
58264-0082-12020-01-31C16284748780-19d75b9d0-3ca0-f424-e053-dadaa90a57ceD-81

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0082-1D8129.57 mL in 1 BOTTLE, GLASSSOLUTION29.574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0082D81 (PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, AND LARREA DIVARICATA WHOLE) SOLUTION [DNA LABS, INC.]4Current NDC, Legacy NDC, 1 package rows20250115_42bffb7a-ca76-4cbb-b5c9-b677e93b6d31.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-008258264-0082-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PASSIFLORA INCARNATA WHOLER48E2W2LMOACTIB
SMILAX ORNATA WHOLESJO6NF5H81ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
STILLINGIA SYLVATICA ROOTQBR70R4FBKACTIB
TRIFOLIUM PRATENSE WHOLEFG30UR681YACTIB
ARCTIUM LAPPA WHOLE73070DU1LAACTIB
PRUNUS DULCIS WHOLEX3EC86GF0ZACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
BERBERIS VULGARIS WHOLE492B79913JACTIB
GLYCYRRHIZA GLABRA WHOLEM1F96IE0ZCACTIB
LARREA DIVARICATA WHOLE89VP85U2R1ACTIB

Source Document#

Source XML · Source PDF

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
D81PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, AND LARREA DIVARICATA WHOLEDNA Labs, Inc.42bffb7a-ca76-4cbb-b5c9-b677e93b6d312025-01-13WarningsExact identifier
ndc (package): 58264-0082-1
ndc (product): 58264-0082
ndc11 (package): 58264008201
spl id: 2b9ed194-def4-363e-e063-6294a90a8cdc
spl set id: 42bffb7a-ca76-4cbb-b5c9-b677e93b6d31

Reported adverse events (FAERS/openFDA)#

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