FDA.reportPublic FDA data

D134

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 02:31:21

Label at a glance#

ProductD134
Active ingredientBLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, TRIBASIC CALCIUM PHOSPHATE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0140-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Muscular pain, stiffness, stress, fatigue.

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTS

INACTIVE INGREDIENT SECTION

Cimicifuga racemosa 3x, Bryonia alba 4x, Rhus toxicodendron 4x, Arnica montana 5x, Causticum 6x, Ferrum phosphoricum 6x, Natrum sulfuricum 6x, Nux vomica 6x, Rhododendron chrysanthum 6x, Colocynthis 6x, Dulcamara 6x, Kalmia latifolia 6x, Magnesia phosphorica 6x, Arsenicum album 8x, Calcarea phosphoricum 8x, 20% 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 134

HOMEOPATHIC 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
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0140-12022-06-06C16284748780-19d75b9d1-1980-f424-e053-dadaa90a57ceD134
58264-0140-12020-01-31C16284748780-19d75b9d1-1980-f424-e053-dadaa90a57ceD134

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0140-1D13429.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0140D134 (BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, AND TRIBASIC CALCIUM PHOSPHATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_a1d4d74a-75ca-45f8-8787-7ac6aa726932.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-014058264-0140-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
BLACK COHOSHK73E24S6X9ACTIB
BRYONIA ALBA WHOLE56K0VVT47PACTIB
TOXICODENDRON PUBESCENS WHOLEC1S185Y74SACTIB
ARNICA MONTANAO80TY208ZWACTIB
CAUSTICUMDD5FO1WKFUACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
SODIUM SULFATE ANHYDROUS36KCS0R750ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
RHODODENDRON AUREUM WHOLEMM2Y21LFITACTIB
CITRULLUS COLOCYNTHIS WHOLEZ70W98921VACTIB
SOLANUM DULCAMARA WHOLEG72JA9DHK5ACTIB
KALMIA LATIFOLIA WHOLEP1SWF7DK1YACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM

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
D134BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, AND TRIBASIC CALCIUM PHOSPHATEDNA Labs, Inc.a1d4d74a-75ca-45f8-8787-7ac6aa7269322025-01-13WarningsExact identifier
ndc (package): 58264-0140-1
ndc (product): 58264-0140
ndc11 (package): 58264014001
spl id: 2b9edb0e-499f-f422-e063-6294a90ae8fa
spl set id: a1d4d74a-75ca-45f8-8787-7ac6aa726932

Reported adverse events (FAERS/openFDA)#

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