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
ARSENIC TRIOXIDE30 [hp_C]/mL
ASPERGILLUS FUMIGATUS200 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER200 [hp_X]/mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS200 [hp_X]/mL
BOLETUS SATANAS FRUITING BODY200 [hp_X]/mL
BOTRYTIS CINEREA200 [hp_X]/mL
CANDIDA ALBICANS30 [hp_C]/mL
CARBO ANIMALIS30 [hp_C]/mL
COCHLIOBOLUS SATIVUS200 [hp_X]/mL
FUSARIUM OXYSPORUM200 [hp_X]/mL
LACHESIS MUTA VENOM30 [hp_C]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_C]/mL
MERCURIUS SOLUBILIS30 [hp_C]/mL
NITRIC ACID30 [hp_C]/mL
PHOSPHORUS30 [hp_C]/mL
PULSATILLA VULGARIS WHOLE30 [hp_C]/mL
RHIZOPUS STOLONIFER200 [hp_X]/mL
SEPIA OFFICINALIS JUICE30 [hp_C]/mL
SILICON DIOXIDE30 [hp_C]/mL
THUJA OCCIDENTALIS LEAFY TWIG30 [hp_C]/mL
USTILAGO MAYDIS200 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii52B29REC7H, S7V92P67HO, X88DF51T48, 9IOA40ANG6, D1A2NG69CK, 68OG1407SM, TBW53313S7, 4D7G21HDBC, 279O8I0433, 3LN5B70U4W, 5398RXP8KU, VSW71SS07I, C88X29Y479, 324Y4038G2, 411VRN1TV4, 27YLU75U4W, I76KB35JEV, FEE198DK4Q, QDL83WN8C2, ETJ7Z6XBU4

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

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 ml2021-12-01NoNoHistorical