Mycotox

Product NDC
83027-0133
11-digit product format
830270133
Labeler code
83027
Product ID
83027-0133_ef86dc9d-444e-48c3-a41c-0db9a638b5bc
Type
HUMAN OTC DRUG
Nonproprietary name
Glandula Suprarenalis (Bovine), Spleen (Bovine), Tabebuia Impetiginosa (Pau D Arco), Thuja Occidentalis, Thymus (Ovine), Thyroidinum (Bovine), Borax, Colchicum Autumnale, Lacticum Acidum, Lymph Node (Suis), Arsenicum Album, Zincum Metallicum, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Torula Cerevisiae, Alternaria Tenuis Nees, Candida Krusei, Rhizopus Nigricans, Candida Tropicalis
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-09-25
Substance
ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CANDIDA TROPICALIS; COLCHICUM AUTUMNALE BULB; HANDROANTHUS IMPETIGINOSUS BARK; ISSATCHENKIA ORIENTALIS WHOLE; LACTIC ACID, DL-; LAMB; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SODIUM BORATE; SUS SCROFA LYMPH; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE; ZINC
Active strength
60; 12; 16; 6; 6; 16; 16; 32; 6; 6; 16; 6; 6; 16; 16; 16; 6; 8; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
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], Dietary Proteins [CS], Dietary 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 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], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food 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
Mycotox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOS TAURUS ADRENAL GLAND60 [hp_X]/mL
BOS TAURUS SPLEEN12 [hp_X]/mL
HANDROANTHUS IMPETIGINOSUS BARK16 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]/mL
LAMB6 [hp_X]/mL
THYROID, BOVINE16 [hp_X]/mL
SODIUM BORATE16 [hp_X]/mL
COLCHICUM AUTUMNALE BULB32 [hp_C]/mL
LACTIC ACID, DL-6 [hp_X]/mL
SUS SCROFA LYMPH6 [hp_X]/mL
ARSENIC TRIOXIDE16 [hp_C]/mL
ZINC6 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER6 [hp_X]/mL
CANDIDA ALBICANS16 [hp_X]/mL
CANDIDA PARAPSILOSIS16 [hp_C]/mL
MUCOR RACEMOSUS16 [hp_X]/mL
SACCHAROMYCES CEREVISIAE6 [hp_X]/mL
ALTERNARIA ALTERNATA8 [hp_X]/mL
ISSATCHENKIA ORIENTALIS WHOLE6 [hp_X]/mL
RHIZOPUS STOLONIFER6 [hp_X]/mL
CANDIDA TROPICALIS12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M2776SWB29Internal UNII lookup
190Q9MB3U3Internal UNII lookup
6GLA1946WXInternal UNII lookup
1NT28V9397Internal UNII lookup
FOF26T73HAInternal UNII lookup
MN18OTN73WInternal UNII lookup
91MBZ8H3QOInternal UNII lookup
993QHL78E6Internal UNII lookup
3B8D35Y7S4Internal UNII lookup
33A7VYU29LInternal UNII lookup
S7V92P67HOInternal UNII lookup
J41CSQ7QDSInternal UNII lookup
9IOA40ANG6Internal UNII lookup
4D7G21HDBCInternal UNII lookup
0KZ676D44NInternal UNII lookup
17RH99LQ7GInternal UNII lookup
978D8U419HInternal UNII lookup
52B29REC7HInternal UNII lookup
138TJ2U1SDInternal UNII lookup
FEE198DK4QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f19eca09-6733-41e7-b0a9-94d5a3d8a728Available 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
83027-0133-1Mycotox60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0133MYCOTOX (GLANDULA SUPRARENALIS (BOVINE), SPLEEN (BOVINE), TABEBUIA IMPETIGINOSA (PAU D ARCO), THUJA OCCIDENTALIS, THYMUS (OVINE), THYROIDINUM (BOVINE), BORAX, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYMPH NODE (SUIS), ARSENICUM ALBUM, ZINCUM METALLICUM, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, MUCOR RACEMOSUS, TORULA CEREVISIAE, ALTERNARIA TENUIS NEES, CANDIDA KRUSEI, RHIZOPUS NIGRICANS, CANDIDA TROPICALIS) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20240927_f19eca09-6733-41e7-b0a9-94d5a3d8a728.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
MycotoxGLANDULA SUPRARENALIS (BOVINE), SPLEEN (BOVINE), TABEBUIA IMPETIGINOSA (PAU D ARCO), THUJA OCCIDENTALIS, THYMUS (OVINE), THYROIDINUM (BOVINE), BORAX, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYMPH NODE (SUIS), ARSENICUM ALBUM, ZINCUM METALLICUM, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, MUCOR RACEMOSUS, TORULA CEREVISIAE, ALTERNARIA TENUIS NEES, CANDIDA KRUSEI, RHIZOPUS NIGRICANS, CANDIDA TROPICALISNutritional Specialties, Inc.f19eca09-6733-41e7-b0a9-94d5a3d8a7282024-09-25WarningsExact identifier
ndc (product): 83027-0133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0133-18302701330160 mL in 1 BOTTLE, SPRAY (83027-0133-1) 60 ml2024-09-25NoNoCurrent