FDA.reportPublic FDA data

A-22

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 02:31:00

Label at a glance#

ProductA-22
Active ingredientASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTI
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0314-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Allergies.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Aspergillus: Flavus 6/12/30x, Fumigatus 6/12/30x, Glaucus 6/12/30x, Nidulans 6/12/30x, Niger 6/12/30x, Penicillium: Camemberti 6/12/30x, Chrysogenum 6/12/30x, Digitatum 6/12/30x, Notatum 6/12/30x, Roqueforti 6/12/30x, 20% alcohol in purified water.

SUGGESTED DOSAGE

DOSAGE & ADMINISTRATION SECTION

Normal dose for the first week is 2-3 drops in water T.I.D. Add one drop per dose per week until a total of ten drops is reached.

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.

A-22
MOLD MIX #2

HOMEOPATHIC ANTIGEN

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
58264-0314-12022-05-30C16284748780-19d75b9cf-f8f9-f424-e053-dadaa90a57ceA-22
58264-0314-12020-01-31C16284748780-19d75b9cf-f8f9-f424-e053-dadaa90a57ceA-22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0314-1A-2229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0314A-22 (ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, AND PENICILLIUM ROQUEFORTI) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_b8a80814-603c-4941-bc2d-4f3d888769a6.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-031458264-0314-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ASPERGILLUS FLAVUS3J888Y9L13ACTIB
ASPERGILLUS FUMIGATUSX88DF51T48ACTIB
EUROTIUM HERBARIORUM49W168AES4ACTIB
ASPERGILLUS NIDULANS242A53RB80ACTIB
ASPERGILLUS NIGER VAR. NIGER9IOA40ANG6ACTIB
PENICILLIUM CAMEMBERTIT069R9OPVGACTIB
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM3Y1PE1GCIGACTIB
PENICILLIUM DIGITATUM1SB49SV239ACTIB
PENICILLIUM ROQUEFORTI7ORP6R724LACTIB

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
A-22ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, AND PENICILLIUM ROQUEFORTIDNA Labs, Inc.b8a80814-603c-4941-bc2d-4f3d888769a62025-01-09WarningsExact identifier
ndc (package): 58264-0314-1
ndc (product): 58264-0314
ndc11 (package): 58264031401
spl id: 2b50d0ac-9542-eba3-e063-6394a90ade3d
spl set id: b8a80814-603c-4941-bc2d-4f3d888769a6

Reported adverse events (FAERS/openFDA)#

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