FDA.reportPublic FDA data

ALLERGY SOUTH EAST MIX

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:16

Label at a glance#

ProductALLERGY SOUTH EAST MIX
Active ingredientBETULA PENDULA WHOLE, ARTEMISIA VULGARIS POLLEN, PLANTAGO LANCEOLATA POLLEN, ACER NEGUNDO WOOD, QUERCUS SPP. WHOLE, CHENOPODIUM ALBUM WHOLE, PINUS SPP. WHOLE, AMBROSIA CONFERTIFLORA WHOLE, JUNIPERUS VIRGINIANA POLLEN, MORUS RUBRA WHOLE, RUMEX ACETOSELLA WHOLE, POPULUS ALBA WHOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amount of: Birch mix 6X, Common Mugwort 6X, English Plantain 6X, Maple Mix 6X, Oak Mix #2 6X, Pigweed Mix 6X, Pine Mix 6X, Ragweed Mix #2 6X, Red Cedar 6X, Red Mulberry 6X, Sheep Sorrel 6X,  White Poplar 6X.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves sneezing, watery-itchy eyes, coughing, nasal congestion, runny nose &/or other symptoms related to outdoor allergies.**

OTC - PURPOSE SECTION

USES: Temporarily relieves sneezing, watery-itchy eyes, coughing, nasal congestion, runny nose &/or other symptoms related to outdoor allergies.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years, spray 2 full sprays under the tongue 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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: Citric Acid, Ethyl Alcohol USP, Glycerin 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: 43406-0223-1

ALLERGY SOUTH EAST MIX

HOMEOPATHIC

1 fl oz (30 mL) / 10% Alcohol

877730004321

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730004321GTIN-13: 0877730004321
EAN-13: 0877730004321
GTIN-12: 877730004321
UPC-A: 877730004321
GTIN storage (14 digits): 00877730004321		ALLERGY SOUTH EAST MIX.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0223-12021-11-09C16284748780-1ba0f9c33-1137-a910-e053-dadaa90a0b85ALLERGY SOUTH EAST MIX
43406-0223-12021-11-09C16284748780-1ba0f9c33-1137-a910-e053-dadaa90a0b85ALLERGY SOUTH EAST MIX
43406-0223-12021-01-29C16284748780-1ba0f9c33-1137-a910-e053-dadaa90a0b85ALLERGY SOUTH EAST MIX
43406-0223-12021-01-29C16284748780-1ba0f9c33-1137-a910-e053-dadaa90a0b85ALLERGY SOUTH EAST MIX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0223-1ALLERGY SOUTH EAST MIX30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-022343406-0223-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETULA PENDULA WHOLE18J93016ITACTIB
ARTEMISIA VULGARIS POLLENANT994T71DACTIB
PLANTAGO LANCEOLATA POLLENDO87T1U2CIACTIB
ACER NEGUNDO WOODMGR889C1JEACTIB
QUERCUS SPP. WHOLEMF4E5I2OUQACTIB
CHENOPODIUM ALBUM WHOLEO417YBE692ACTIB
PINUS SPP. WHOLENT5UBA3P7ZACTIB
AMBROSIA CONFERTIFLORA WHOLEIM2D62E64FACTIB
JUNIPERUS VIRGINIANA POLLENPY0JA16R2GACTIB
MORUS RUBRA WHOLENIJ0Z7376AACTIB
RUMEX ACETOSELLA WHOLED4MF746504ACTIB
POPULUS ALBA WHOLEY05EGY83Y4ACTIB
CITRIC ACID ACETATEDSO12WL7AUIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22021-11-09full-release2026-06-01 02:15:08

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 SOUTH EAST MIXBIRCH MIX, COMMON MUGWORT, ENGLISH PLANTAIN, MAPLE MIX, PIGWEED MIX, PINE MIX, RAGWEED MIX, RED CEDAR, RED MULBERRY, SHEEP SORREL, WHITE POPLARNatural Creations, Inc13d95abb-52ac-431b-8a90-84e7367659cf2025-11-03WarningsExact identifier
ndc (package): 43406-0223-1
ndc (product): 43406-0223
ndc11 (package): 43406022301
spl id: d2b82941-a8a2-4cee-a2bf-34e4054f65b6
spl set id: 13d95abb-52ac-431b-8a90-84e7367659cf

Reported adverse events (FAERS/openFDA)#

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