FDA.reportPublic FDA data

D-49

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-49
Active ingredientARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MERCURIC SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PRATENSIS, SEPIA OFFICINALIS JUICE, SULFUR
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0049-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Acute inflammation of the sinus.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Arsenicum album 12x, Calcarea carbonica 30x, Cinnabaris 12x, Kalium bichromicum 12x, Mercurius solubilis 30x, Pulsatilla nigricans 12x, Sepia officinalis 12x, Sulphur 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 49

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0049-12022-06-02C16284748780-19d75b9cf-cf68-f424-e053-dadaa90a57ceD-49
58264-0049-12020-01-31C16284748780-19d75b9cf-cf68-f424-e053-dadaa90a57ceD-49

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0049-1D-4929.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0049D-49 (ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MERCURIC SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PRATENSIS, SEPIA OFFICINALIS JUICE, AND SULFUR) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_26800b04-81c7-4094-afe8-4db6ca878f6d.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
58264-004958264-0049-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
MERCURIC SULFIDEZI0T668SF1ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
ANEMONE PRATENSIS8E272251DIACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB

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-49ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MERCURIC SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PRATENSIS, SEPIA OFFICINALIS JUICE, AND SULFURDNA Labs, Inc.26800b04-81c7-4094-afe8-4db6ca878f6d2025-01-13WarningsExact identifier
ndc (package): 58264-0049-1
ndc (product): 58264-0049
ndc11 (package): 58264004901
spl id: 2b9ec8dd-73af-e366-e063-6394a90ae792
spl set id: 26800b04-81c7-4094-afe8-4db6ca878f6d

Reported adverse events (FAERS/openFDA)#

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