FDA.reportPublic FDA data

D-85

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 02:31:19

Label at a glance#

ProductD-85
Active ingredientHYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CORN SILK, ELYMUS REPENS ROOT, AGATHOSMA CRENULATA LEAF, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, DIBASIC POTASSIUM PHOSPHATE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0091-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Water retention, edema.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Hydrangea arborescens 1x, Sabal serrulata 1x, Stigmata maidis 1x, Triticum repens 1x, Barosma crenata 1x, Natrum phosphoricum 1x, Kalium phosphoricum 1x

INACTIVE

INACTIVE INGREDIENT SECTION

30% 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 85

HOMEOPATHIC
STRESS 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
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0091-12022-06-06C16284748780-19d75b9d1-12e7-f424-e053-dadaa90a57ceD-85
58264-0091-12020-01-31C16284748780-19d75b9d1-12e7-f424-e053-dadaa90a57ceD-85

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0091-1D-8529.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0091D-85 (HYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CORN SILK, ELYMUS REPENS ROOT, AGATHOSMA CRENULATA LEAF, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND DIBASIC POTASSIUM PHOSPHATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_83f43207-76bb-4fc0-b3fc-45614da43e23.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-009158264-0091-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
HYDRANGEA ARBORESCENS ROOTSFK828Q2DEACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
CORN SILK7D3VB244UXACTIB
ELYMUS REPENS ROOT3IXW0F6P8WACTIB
AGATHOSMA CRENULATA LEAFIIV9247F0WACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB

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-85HYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CORN SILK, ELYMUS REPENS ROOT, AGATHOSMA CRENULATA LEAF, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.83f43207-76bb-4fc0-b3fc-45614da43e232025-01-13WarningsExact identifier
ndc (package): 58264-0091-1
ndc (product): 58264-0091
ndc11 (package): 58264009101
spl id: 2b9ed994-a881-0e65-e063-6394a90aca84
spl set id: 83f43207-76bb-4fc0-b3fc-45614da43e23

Reported adverse events (FAERS/openFDA)#

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