FDA.reportPublic FDA data

N-13

Manufacturer
DNA Labs, Inc.
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:30:13

Label at a glance#

ProductN-13
Active ingredientCEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, SUS SCROFA SPLEEN
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0211-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Support for the Spleen; Blood and Immune system.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Ceanothus 4x, Urtica urens 4x, Natrum muriaticum 6x, Lachesis mutus 12x, Cinchona officinalis 8x, Lycopodium clavatum 6x, Ferrum muriaticum 6x, Spleen 6/12/30/60/200x

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

SPL UNCLASSIFIED 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.

N-13
SPLEEN ENERGIZER

HOMEOPATHIC ENDOCRINE

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
58264-0211-12022-06-06C16284748780-19d75b9d0-6973-f424-e053-dadaa90a57ceN-13
58264-0211-12020-01-31C16284748780-19d75b9d0-6973-f424-e053-dadaa90a57ceN-13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0211-1N-1329.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0211N-13 (CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEEN) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_146c5465-bcd9-4057-8975-dc1088b9971b.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
58264-021158264-0211-1

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
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
URTICA URENSIHN2NQ5OF9ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
LACHESIS MUTA WHOLE6Y582I290CACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
LYCOPODIUM CLAVATUM WHOLE005ICF6L27ACTIB
FERRIC CHLORIDE HEXAHYDRATE0I2XIN602UACTIM
SUS SCROFA SPLEEN92AMN5J79YACTIB

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
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
ndc (package): 58264-0211-1
ndc (product): 58264-0211
ndc11 (package): 58264021101
spl id: 2b538be3-baa8-3c2b-e063-6294a90a1489
spl set id: 146c5465-bcd9-4057-8975-dc1088b9971b

Reported adverse events (FAERS/openFDA)#

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