FDA.reportPublic FDA data

AM-12

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 02:30:22

Label at a glance#

ProductAM-12
Active ingredientSTRYCHNOS IGNATII WHOLE, FERROSOFERRIC PHOSPHATE, SEPIA OFFICINALIS JUICE
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0351-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Regulates energy flow in the bladder meridian.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Ignatia amara 8x, Ferrum phosphoricum 8x, Sepia 12x, aa partes, 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

SPL UNCLASSIFIED SECTION

  • Use only if cap seal is unbroken.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • As with drugs if you are pregnant or nursing a baby seek professional advice before using this product.

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-12
BLADDER

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
58264-0351-12022-06-02C16284748780-19d75b9d0-1090-f424-e053-dadaa90a57ceAM-12
58264-0351-12020-01-31C16284748780-19d75b9d0-1090-f424-e053-dadaa90a57ceAM-12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0351-1AM-1229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0351AM-12 (STRYCHNOS IGNATII WHOLE, FERROSOFERRIC PHOSPHATE, AND SEPIA OFFICINALIS JUICE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_66d09a87-0b36-410a-be7c-338258d8e591.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
58264-035158264-0351-1

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
STRYCHNOS IGNATII WHOLE6YSJ329777ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB

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
AM-12STRYCHNOS IGNATII WHOLE, FERROSOFERRIC PHOSPHATE, AND SEPIA OFFICINALIS JUICEDNA Labs, Inc.66d09a87-0b36-410a-be7c-338258d8e5912025-01-09WarningsExact identifier
ndc (package): 58264-0351-1
ndc (product): 58264-0351
ndc11 (package): 58264035101
spl id: 2b530b6e-548b-547a-e063-6394a90a113f
spl set id: 66d09a87-0b36-410a-be7c-338258d8e591

Reported adverse events (FAERS/openFDA)#

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