FDA.reportPublic FDA data

ALLERGY ATLANTIC MOLD MIX

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:29:48

Label at a glance#

ProductALLERGY ATLANTIC MOLD MIX
Active ingredientALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, BOTRYTIS CINEREA, RHIZOPUS STOLONIFER, USTILAGO MAYDIS
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amounts of: ​Alternaria Alternata 8X, Aspergillus Fumigatus 8X, Botrytis Cinerea 8X, Mucor Mucedo 8X, Ustilago Maidis 8x.

OTC - PURPOSE SECTION

USES:  Temporarily relieves symptoms related to mold allergies.**

INDICATIONS & USAGE SECTION

USES:  Temporarily  relieves symptoms related to mold allergies.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:  Adults & children above 12 years:  10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS:

  *Consult a physician for use in children under 12 years of age.

  * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

  * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion) get    medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  *Consult a physician for use in children under 12 years of age.

  * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

  * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion) get    medical help or contact a Poison Control Center right away.

  * Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ehtyl Alchohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

 Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0587-1

ALLERGY ATLANTIC

        MOLD MIX

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730003898 NON GMO Logo

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0587-12022-02-17C16284748780-1d6a99b39-51e3-a426-e053-dadaa90af4c2ALLERGY ATLANTIC MOLD MIX
43406-0587-12022-01-28C16284748780-1d6a99b39-51e3-a426-e053-dadaa90af4c2ALLERGY ATLANTIC MOLD MIX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0587-1ALLERGY ATLANTIC MOLD MIX30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0587ALLERGY ATLANTIC MOLD MIX (ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, BOTRYTIS CINEREA, RHIZOPUS STOLONIFER, USTILAGO MAYDIS) LIQUID [NATURAL CREATIONS, INC.]5Current NDC, Legacy NDC, 1 package rows20241224_37ea5d4c-b443-4465-b97f-449c76f13af9.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-058743406-0587-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALTERNARIA ALTERNATA52B29REC7HACTIB
ASPERGILLUS FUMIGATUSX88DF51T48ACTIB
BOTRYTIS CINEREATBW53313S7ACTIB
RHIZOPUS STOLONIFERFEE198DK4QACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
ALLERGY ATLANTIC MOLD MIXALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, BOTRYTIS CINEREA, RHIZOPUS STOLONIFER, USTILAGO MAYDISNatural Creations, Inc.37ea5d4c-b443-4465-b97f-449c76f13af92024-12-19WarningsExact identifier
ndc (package): 43406-0587-1
ndc (product): 43406-0587
ndc11 (package): 43406058701
spl id: e1267a37-7517-45f6-aaf8-0b490255e8a4
spl set id: 37ea5d4c-b443-4465-b97f-449c76f13af9

Reported adverse events (FAERS/openFDA)#

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