FDA.reportPublic FDA data

D-48

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 02:31:10

Label at a glance#

ProductD-48
Active ingredientPICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, FERROSOFERRIC PHOSPHATE
Label structure9 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0048-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Pulmonary diseases.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Acidum picricum 8x, Bryonia 12x, Cinchona officinalis 6x, Dulcamara 30x, Kalium carbonicum 6x, Phosphorus 30x, Sepia officinalis 6x, Silicea 30x, Lycopodium clavatum 30x, Ferrum phosphoricum 12x

INACTIVE

INACTIVE INGREDIENT SECTION

20% alcohol in purified water.

Rx CAUTION

SPL UNCLASSIFIED SECTION

Federal law prohibits dispensing without a prescription.

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 48

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
58264-0048-12022-06-02C16284748780-19d75b9cf-fab2-f424-e053-dadaa90a57ceD-48
58264-0048-12020-01-31C16284748780-19d75b9cf-fab2-f424-e053-dadaa90a57ceD-48

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0048-1D-4829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0048D-48 (PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_1d55827f-0ea2-4eda-ae43-7c0723e5708e.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
58264-004858264-0048-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PICRIC ACIDA49OS0F91SACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
SOLANUM DULCAMARA WHOLEG72JA9DHK5ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
PHOSPHORUS27YLU75U4WACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB

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-48PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATEDNA Labs, Inc.1d55827f-0ea2-4eda-ae43-7c0723e5708e2025-01-13WarningsExact identifier
ndc (package): 58264-0048-1
ndc (product): 58264-0048
ndc11 (package): 58264004801
spl id: 2b9ec82d-e5f5-ae16-e063-6394a90a5559
spl set id: 1d55827f-0ea2-4eda-ae43-7c0723e5708e

Reported adverse events (FAERS/openFDA)#

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