FDA.reportPublic FDA data

D-118

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 02:31:17

Label at a glance#

ProductD-118
Active ingredientTOXICODENDRON PUBESCENS LEAF, PUNICA GRANATUM ROOT BARK, ARISAEMA TRIPHYLLUM ROOT, KEROSENE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0124-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Temporomandibular joint syndrome (TMJ).

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Rhus toxicodendron 30x, Granatum 6x, Arum triphyllum 30x, Petroleum 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 118

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
58264-0124-12022-06-06C16284748780-19d75b9d0-6256-f424-e053-dadaa90a57ceD-118
58264-0124-12020-01-31C16284748780-19d75b9d0-6256-f424-e053-dadaa90a57ceD-118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0124-1D-11829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0124D-118 (TOXICODENDRON PUBESCENS LEAF, PUNICA GRANATUM ROOT BARK, ARISAEMA TRIPHYLLUM ROOT, AND KEROSENE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_697add39-8767-43cd-bcd1-16a961160f70.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-012458264-0124-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
PUNICA GRANATUM ROOT BARKCLV24I3T1DACTIB
ARISAEMA TRIPHYLLUM ROOTDM64K844DMACTIB
KEROSENE1C89KKC04EACTIB

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-118TOXICODENDRON PUBESCENS LEAF, PUNICA GRANATUM ROOT BARK, ARISAEMA TRIPHYLLUM ROOT, AND KEROSENEDNA Labs, Inc.697add39-8767-43cd-bcd1-16a961160f702025-01-13WarningsExact identifier
ndc (package): 58264-0124-1
ndc (product): 58264-0124
ndc11 (package): 58264012401
spl id: 2b9eda10-4e9f-e31e-e063-6394a90a53c6
spl set id: 697add39-8767-43cd-bcd1-16a961160f70

Reported adverse events (FAERS/openFDA)#

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