FDA.reportPublic FDA data

Mold Antigens

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:01

Label at a glance#

ProductMold Antigens
Active ingredientALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, SACCHAROMYCES CEREVISIAE, MUCOR RACEMOSUS, ARSENIC TRIOXIDE, PHOSPHORUS, PULSATILLA PRATENSIS WHOLE, SEPIA OFFICINALIS JUICE, RHIZOPUS STOLONIFER
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 7.69% of Arsenicum Album 12X, 30X, Mucor Racemosus 30X, 200X, Phosphorus 12X, 30X, Pulsatilla 12X, 30X, Rhizopus Nigricans 30C, 200C, Sepia 12X, 30X; 3.85% of Alternaria Tenuis Nees 30X, 200X, Candida Albicans 30X, 200X, Candida Parapsilosis 30X, 200X, Torula Cerevisiae 30X, 200X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with mold allergies, such as runny nose.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with mold allergies, such as runny nose.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

ACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MOLD

ANTIGENS

1 fl. oz. (30 ml)

Mold AntigensMold Antigens

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-054844911-0548-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALTERNARIA ALTERNATA52B29REC7HACTIB
ASPERGILLUS NIGER VAR. NIGER9IOA40ANG6ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CANDIDA PARAPSILOSIS0KZ676D44NACTIB
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
MUCOR RACEMOSUS17RH99LQ7GACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
RHIZOPUS STOLONIFERFEE198DK4QACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 (package): 44911-0548-1
ndc (product): 44911-0548
ndc11 (package): 44911054801
spl id: 27c2a32c-051e-4baf-ac2b-35a4b276feac
spl set id: d320a51f-13c0-423a-a7fe-ff88b56678ac

Reported adverse events (FAERS/openFDA)#

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