Mold Antigen

Product NDC
81825-0002
11-digit product format
818250002
Labeler code
81825
Product ID
81825-0002_539d3aeb-4490-4871-adf9-3db0d41c56a9
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
Zorex International
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-12-01
Substance
ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; CARBO ANIMALIS; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; RHIZOPUS STOLONIFER; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; USTILAGO MAYDIS
Active strength
200; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mold Antigen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTERNARIA ALTERNATA200 [hp_X]/mL
ASPERGILLUS FUMIGATUS30 [hp_C]/mL
ASPERGILLUS NIGER VAR. NIGER200 [hp_X]/mL
BOLETUS SATANAS FRUITING BODY200 [hp_X]/mL
BOTRYTIS CINEREA200 [hp_X]/mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS200 [hp_X]/mL
FUSARIUM OXYSPORUM200 [hp_X]/mL
COCHLIOBOLUS SATIVUS30 [hp_C]/mL
RHIZOPUS STOLONIFER30 [hp_C]/mL
USTILAGO MAYDIS200 [hp_X]/mL
ARSENIC TRIOXIDE200 [hp_X]/mL
CANDIDA ALBICANS30 [hp_C]/mL
CARBO ANIMALIS30 [hp_C]/mL
LACHESIS MUTA VENOM30 [hp_C]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_C]/mL
MERCURIUS SOLUBILIS30 [hp_C]/mL
NITRIC ACID30 [hp_C]/mL
PHOSPHORUS200 [hp_X]/mL
PULSATILLA VULGARIS WHOLE30 [hp_C]/mL
SEPIA OFFICINALIS JUICE30 [hp_C]/mL
SILICON DIOXIDE30 [hp_C]/mL
THUJA OCCIDENTALIS LEAFY TWIG200 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52B29REC7HInternal UNII lookup
X88DF51T48Internal UNII lookup
9IOA40ANG6Internal UNII lookup
68OG1407SMInternal UNII lookup
TBW53313S7Internal UNII lookup
D1A2NG69CKInternal UNII lookup
5398RXP8KUInternal UNII lookup
3LN5B70U4WInternal UNII lookup
FEE198DK4QInternal UNII lookup
4K7Z7K7SWGInternal UNII lookup
S7V92P67HOInternal UNII lookup
4D7G21HDBCInternal UNII lookup
279O8I0433Internal UNII lookup
VSW71SS07IInternal UNII lookup
C88X29Y479Internal UNII lookup
324Y4038G2Internal UNII lookup
411VRN1TV4Internal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
QDL83WN8C2Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff92e909-b5a7-417f-98a4-551f1576fd1eAvailable on FDA.report

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

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 (product): 81825-0002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81825-0002-18182500020130 mL in 1 BOTTLE, DROPPER (81825-0002-1) 30 ml2021-12-01NoNoCurrent