FDA.reportPublic FDA data

AM-9

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 02:31:04

Label at a glance#

ProductAM-9
Active ingredientSPIGELIA ANTHELMIA, SILICON DIOXIDE, CORALLIUM RUBRUM WHOLE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0348-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Regulates energy flow in the triplewarmer meridian.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Spigelia anthelmia 8x, Silicea 8x, Corallium rubrum 10x

INACTIVE

INACTIVE INGREDIENT SECTION

20% alcohol in purified water.

SUGGESTED DOSAGE

DOSAGE & ADMINISTRATION SECTION

5 to 10 drops twice a day, meridian energy excess 1 to 5 drops t.i.d, meridian lacking in energy 10 to 20 drops t.i.d.

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.

AM-9
TRIPLEWARMER

ACUPUNCTURE MERIDIAN

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
58264-0348-12022-06-02C16284748780-19d75b9d1-199b-f424-e053-dadaa90a57ceAM-9
58264-0348-12020-01-31C16284748780-19d75b9d1-199b-f424-e053-dadaa90a57ceAM-9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0348-1AM-929.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0348AM-9 (SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_d7a00f0b-de4c-4bff-b8e0-86a82bed8bb9.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-034858264-0348-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SPIGELIA ANTHELMIAWYT05213GEACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CORALLIUM RUBRUM WHOLE22Z32PWR7RACTIB

Source Document#

Source XML · Source PDF

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
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
ndc (package): 58264-0348-1
ndc (product): 58264-0348
ndc11 (package): 58264034801
spl id: 2b52e035-8802-a7f5-e063-6294a90ad8bd
spl set id: d7a00f0b-de4c-4bff-b8e0-86a82bed8bb9

Reported adverse events (FAERS/openFDA)#

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