FDA.reportPublic FDA data

D-115

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 02:31:11

Label at a glance#

ProductD-115
Active ingredientCAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, SILVER NITRATE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0121-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Bleeding gums.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Causticum 12x, 30x, Hamamelis virginiana 6x, 30x, Iodium 6x, Arsenicum album 4x, 30x, Baryta carbonica 8x, 30x, Echinacea angustifolia 4x, 12x, Aluminum metallicum 9x, 30x, Antimonium crudum 8x, 12/x, Nux vomica 4x, 30x, Staphysagria 4x, 30x, Acidum sulfuricum 4x, 30x, Hepar sulphuris calcareum 8x, 30x, Argentum nitricum 4x, 30x

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 115

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
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0121-12022-06-06C16284748780-19d75b9d0-8f80-f424-e053-dadaa90a57ceD-115
58264-0121-12020-01-31C16284748780-19d75b9d0-8f80-f424-e053-dadaa90a57ceD-115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0121-1D-11529.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0121D-115 (CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_247a9133-fe4b-42a0-b3f3-7cb62eaec8c4.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-012158264-0121-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
CAUSTICUMDD5FO1WKFUACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
IODINE9679TC07X4ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
ALUMINUMCPD4NFA903ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
SULFURIC ACIDO40UQP6WCFACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
SILVER NITRATE95IT3W8JZEACTIB

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-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
ndc (package): 58264-0121-1
ndc (product): 58264-0121
ndc11 (package): 58264012101
spl id: 2b9efed7-5d88-16bd-e063-6394a90ac14f
spl set id: 247a9133-fe4b-42a0-b3f3-7cb62eaec8c4

Reported adverse events (FAERS/openFDA)#

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