FDA.reportPublic FDA data

AM-8

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 02:31:01

Label at a glance#

ProductAM-8
Active ingredientATROPA BELLADONNA, CALCIUM SULFATE ANHYDROUS, FORMICA RUFA
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0347-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Regulates energy flow in the gallbladder meridian.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Belladonna 8x, Calcarea sulphuricum 8x, Formica rufa 12x

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-8
GALLBLADDER

ACUPUNCTURE MERIDIAN

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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0347-12022-06-02C16284748780-19d75b9d1-1923-f424-e053-dadaa90a57ceAM-8
58264-0347-12020-01-31C16284748780-19d75b9d1-1923-f424-e053-dadaa90a57ceAM-8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0347-1AM-829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0347AM-8 (ATROPA BELLADONNA, CALCIUM SULFATE ANHYDROUS, AND FORMICA RUFA) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_c313d3e3-11a2-45f7-8b87-1bf5d1019137.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-034758264-0347-1

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
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB
FORMICA RUFA55H0W83JO5ACTIB

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-8ATROPA BELLADONNA, CALCIUM SULFATE ANHYDROUS, AND FORMICA RUFADNA Labs, Inc.c313d3e3-11a2-45f7-8b87-1bf5d10191372025-01-09WarningsExact identifier
ndc (package): 58264-0347-1
ndc (product): 58264-0347
ndc11 (package): 58264034701
spl id: 2b52dd9d-5def-a801-e063-6294a90aeffa
spl set id: c313d3e3-11a2-45f7-8b87-1bf5d1019137

Reported adverse events (FAERS/openFDA)#

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