FDA.reportPublic FDA data

Grain and Seed Antigens

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:21:29

Label at a glance#

ProductGrain and Seed Antigens
Active ingredientAMARANTHUS CRUENTUS SEED, BAMBUSA VULGARIS STEM, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTIL, MILLET, SORGHUM BICOLOR WHOLE, OAT, POPPY SEED, WHITE RICE, RYE, SESAME SEED, SOYBEAN, SUCROSE, SUNFLOWER SEED, WHEAT, ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, SULFUR
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Amaranth 9X, 12X, 15X, 30X, Bamboo 9X, 12X, 15X, 30X Barley 9X, 12X, 15X, 30X, Buckwheat 9X, 12X, 15X, 30X, Corn 9X, 12X, 15X, 30X, Flax Seed 9X, 12X, 15X, 30X, Lentils 9X, 12X, 15X, 30X, Millet 9X, 12X, 15X, 30X, Milo 9X, 12X, 15X, 30X, Oat 9X, 12X, 15X, 30X, Poppy Seed 9X, 12X, 15X, 30X, Rice 9X, 12X, 15X, 30X, Rye 9X, 12X, 15X, 30X, Sesame 9X, 12X, 15X, 30X, Soybean 9X, 12X, 15X, 30X, Sugarcane 9X, 12X, 15X, 30X, Sunflower Seed 9X, 12X, 15X, 30X, Wheat 9X, 12X, 15X, 30X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Sulphur 12X.

PURPOSE:

OTC - PURPOSE SECTION

For temporary relief of allergies due to grain and seeds.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care 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

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of allergies due to grain and seeds.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

GRAIN & SEED ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

GRAIN & SEED ANTIGENSGRAIN & SEED ANTIGENS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0635-1Grain and Seed Antigens30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0635GRAIN AND SEED ANTIGENS (AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, 1 package rows20230623_36ce44a5-e5ac-4eea-b76d-424dcd4e6b07.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-063543857-0635-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMARANTHUS CRUENTUS SEED0C5WAA83X5ACTIB
BAMBUSA VULGARIS STEMSMR633LHTCACTIB
BARLEY5PWM7YLI7RACTIB
BUCKWHEATN0Y68724R3ACTIB
CORN0N8672707OACTIB
FLAX SEED4110YT348CACTIB
LENTIL6O38V6B52OACTIB
MILLETTJR6B3R47PACTIB
SORGHUM BICOLOR WHOLEY3T98X3AL6ACTIB
OATZ6J799EAJKACTIB
POPPY SEED60RO23IR87ACTIB
WHITE RICEA195V20H7AACTIB
RYE0R4AQI398XACTIB
SESAME SEED7Y1255HVXRACTIB
SOYBEANL7HT8F1ZODACTIB
SUCROSEC151H8M554ACTIB
SUNFLOWER SEEDR9N3379M4ZACTIB
WHEAT4J2I0SN84YACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SULFUR70FD1KFU70ACTIB
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
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
ndc (package): 43857-0635-1
ndc (product): 43857-0635
ndc11 (package): 43857063501
spl id: e43fdffb-1196-4de8-b788-a9bd91458b27
spl set id: 36ce44a5-e5ac-4eea-b76d-424dcd4e6b07

Reported adverse events (FAERS/openFDA)#

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