FDA.reportPublic FDA data

Mold Antigen

Manufacturer
Zorex International | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:56

Label at a glance#

ProductMold Antigen
Active ingredientALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER VAR. NIGER, BOLETUS SATANAS FRUITING BODY, BOTRYTIS CINEREA, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, FUSARIUM OXYSPORUM, COCHLIOBOLUS SATIVUS, RHIZOPUS STOLONIFER, USTILAGO MAYDIS, ARSENIC TRIOXIDE, CANDIDA ALBICANS, CARBO ANIMALIS, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, NITRIC ACID, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amounts of: Alternaria Alternata 12X, 30X, 200X, Aspergillus Fumigatus 12X, 30X, 200X, Aspergillus Niger 12X, 30X, 200X, Boletus Sat 12X, 30X, 200X, Botrytis Cinerea 12X, 30X, 200X, Cladosporium Metanigrum 12X, 30X, 200X, Fusarium Oxysporum 12X, 30X, 200X, Helminthosporium 12X, 30X, 200X, Mucor Muecedo 12X, 30X, 200X, Pullularia Pullulans 12X, 30X, 200X, Rhizopus Nigricans 12X, 30X, 200X, Ustilago Maydis 12X, 30X, 200X, Arsenicum Alb 30C, Candida Alb 30C, Carbo An 30C, Lachesis 30C, Lycopodium 30C, Merc Solub 30C, Nitricum Ac 30C, Phosphorus 30C, Pulsatilla 30C, Sepia 30C, Silicea 30C, Thuja Occ 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves symptoms associated with allergies from mold.**

OTC - PURPOSE SECTION

USES: Temporarily relieves symptoms associated with allergies from mold.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Zorex International / Lowell, MI 49331 / 800-679-3027

REFERENCES SECTION

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:81825-0002-1

Mold Antigen

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81825-0002-1Mold Antigen30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81825-0002MOLD ANTIGEN (ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC) LIQUID [ZOREX INTERNATIONAL]1Current NDC, 1 package rows20230420_ff92e909-b5a7-417f-98a4-551f1576fd1e.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81825-000281825-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALTERNARIA ALTERNATA52B29REC7HACTIB
ASPERGILLUS FUMIGATUSX88DF51T48ACTIB
ASPERGILLUS NIGER VAR. NIGER9IOA40ANG6ACTIB
BOLETUS SATANAS FRUITING BODY68OG1407SMACTIB
BOTRYTIS CINEREATBW53313S7ACTIB
AUREOBASIDIUM PULLULANS VAR. PULLUTANSD1A2NG69CKACTIB
FUSARIUM OXYSPORUM5398RXP8KUACTIB
COCHLIOBOLUS SATIVUS3LN5B70U4WACTIB
RHIZOPUS STOLONIFERFEE198DK4QACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CARBO ANIMALIS279O8I0433ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
NITRIC ACID411VRN1TV4ACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCZorex Internationalff92e909-b5a7-417f-98a4-551f1576fd1e2018-12-21WarningsExact identifier
ndc (package): 81825-0002-1
ndc (product): 81825-0002
ndc11 (package): 81825000201
spl id: 539d3aeb-4490-4871-adf9-3db0d41c56a9
spl set id: ff92e909-b5a7-417f-98a4-551f1576fd1e

Reported adverse events (FAERS/openFDA)#

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