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; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE
Active strength
30; 12; 30; 30; 30; 30; 12; 12; 30; 30; 12 [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_X]/mL; [hp_X]/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

Additional Listing Data#

Finished product
Yes
Brand name base
Mold Antigens

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii52B29REC7H, S7V92P67HO, 9IOA40ANG6, 4D7G21HDBC, 0KZ676D44N, 17RH99LQ7G, 27YLU75U4W, 8E272251DI, FEE198DK4Q, 978D8U419H, QDL83WN8C2

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

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