Household Dust and Mold Mix

Product NDC
83027-0123
11-digit product format
830270123
Labeler code
83027
Product ID
83027-0123_e2fece65-4b20-490f-b058-60b87390ea7a
Type
HUMAN OTC DRUG
Nonproprietary name
Glandula Suprarenalis (Bovine), Hepar (Bovine), Histaminum Hydrochloricum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Dust, Mucor Racemosus, Torula Cerevisiae, House Dust Mite, Adrenocorticotrophin, Rhizopus Nigricans
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-08-24
Marketing end
2028-10-31
Substance
BOS TAURUS ADRENAL GLAND; BEEF LIVER; HISTAMINE DIHYDROCHLORIDE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; HOUSE DUST; MUCOR RACEMOSUS; SACCHAROMYCES CEREVISIAE; DERMATOPHAGOIDES PTERONYSSINUS; CORTICOTROPIN; RHIZOPUS STOLONIFER
Active strength
6; 6; 12; 16; 16; 16; 16; 16; 16; 16; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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_C]/mL; [hp_C]/mL
Pharmacologic classes
Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [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], 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], House Dust [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], Insect Proteins [CS], 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 House Dust Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Household Dust and Mold Mix

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOS TAURUS ADRENAL GLAND6 [hp_X]/mL
BEEF LIVER6 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
ALTERNARIA ALTERNATA16 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER16 [hp_X]/mL
CANDIDA ALBICANS16 [hp_X]/mL
CANDIDA PARAPSILOSIS16 [hp_X]/mL
HOUSE DUST16 [hp_X]/mL
MUCOR RACEMOSUS16 [hp_X]/mL
SACCHAROMYCES CEREVISIAE16 [hp_X]/mL
DERMATOPHAGOIDES PTERONYSSINUS12 [hp_C]/mL
CORTICOTROPIN15 [hp_C]/mL
RHIZOPUS STOLONIFER15 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 13 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M2776SWB29Internal UNII lookup
W8N8R55022Internal UNII lookup
3POA0Q644UInternal UNII lookup
52B29REC7HInternal UNII lookup
9IOA40ANG6Internal UNII lookup
4D7G21HDBCInternal UNII lookup
0KZ676D44NInternal UNII lookup
EYO007VX98Internal UNII lookup
17RH99LQ7GInternal UNII lookup
978D8U419HInternal UNII lookup
57L1Z5378KInternal UNII lookup
K0U68Q2TXAInternal 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
39ce30c9-427c-4e6a-a918-d5478e38b609Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7Product name220250121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0123-1Household Dust and Mold Mix60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0123HOUSEHOLD DUST AND MOLD MIX (GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), HISTAMINUM HYDROCHLORICUM, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, DUST, MUCOR RACEMOSUS, TORULA CEREVISIAE, HOUSE DUST MITE, ADRENOCORTICOTROPHIN, RHIZOPUS NIGRICANS) SPRAY [NUTRITIONAL SPECIALTIES, INC.]2Current NDC, 1 package rows20250516_39ce30c9-427c-4e6a-a918-d5478e38b609.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
Household Dust and Mold MixGLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), HISTAMINUM HYDROCHLORICUM, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, DUST, MUCOR RACEMOSUS, TORULA CEREVISIAE, HOUSE DUST MITE, ADRENOCORTICOTROPHIN, RHIZOPUS NIGRICANSNutritional Specialties, Inc.39ce30c9-427c-4e6a-a918-d5478e38b6092025-05-15WarningsExact identifier
ndc (product): 83027-0123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83027-0123-18302701230160 mL in 1 BOTTLE, SPRAY (83027-0123-1) 60 ml2023-08-242028-10-31NoNoHistorical