Mold Antigens

Product NDC
44911-0548
11-digit product format
449110548
Labeler code
44911
Product ID
44911-0548_27c2a32c-051e-4baf-ac2b-35a4b276feac
Type
HUMAN OTC DRUG
Nonproprietary name
Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Torula Cerevisiae, Mucor Racemosus, Arsenicum Album, Phosphorus, Pulsatilla (Pratensis), Sepia, Rhizopus Nigricans
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-05-28
Marketing end
2027-04-12
Substance
ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; SACCHAROMYCES CEREVISIAE; MUCOR RACEMOSUS; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; SEPIA OFFICINALIS JUICE; RHIZOPUS STOLONIFER
Active strength
30; 30; 30; 30; 30; 30; 12; 12; 12; 12; 30 [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
Pharmacologic classes
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], Dietary 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 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 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]
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
Mold Antigens

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTERNARIA ALTERNATA30 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER30 [hp_X]/mL
CANDIDA ALBICANS30 [hp_X]/mL
CANDIDA PARAPSILOSIS30 [hp_X]/mL
SACCHAROMYCES CEREVISIAE30 [hp_X]/mL
MUCOR RACEMOSUS30 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
RHIZOPUS STOLONIFER30 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52B29REC7HInternal UNII lookup
9IOA40ANG6Internal UNII lookup
4D7G21HDBCInternal UNII lookup
0KZ676D44NInternal UNII lookup
978D8U419HInternal UNII lookup
17RH99LQ7GInternal UNII lookup
S7V92P67HOInternal UNII lookup
27YLU75U4WInternal UNII lookup
8E272251DIInternal UNII lookup
QDL83WN8C2Internal 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
d320a51f-13c0-423a-a7fe-ff88b56678acAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0548-12022-03-03C16284748780-1d6a99b39-3ea8-a426-e053-dadaa90af4c2Drug Facts:
44911-0548-12022-01-28C16284748780-1d6a99b39-3ea8-a426-e053-dadaa90af4c2Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0548-1Mold Antigens30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0548MOLD ANTIGENS (ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, RHIZOPUS NIGRICANS) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20231214_d320a51f-13c0-423a-a7fe-ff88b56678ac.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 AntigensALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, RHIZOPUS NIGRICANSEnergique, Inc.d320a51f-13c0-423a-a7fe-ff88b56678ac2023-12-13WarningsExact identifier
ndc (product): 44911-0548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0548-14491105480130 mL in 1 BOTTLE, DROPPER (44911-0548-1) 30 ml2020-05-282027-04-12NoNoCurrent