FDA.reportPublic FDA data

Grain and Seed Antigens

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-06-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:29:42

Label at a glance#

ProductGrain and Seed Antigens
Active ingredientBAMBUSA VULGARIS LEAF, BARLEY, POPPY SEED, CORN, FLAX SEED, BUCKWHEAT, MILLET, SORGHUM BICOLOR WHOLE, OAT, BROWN RICE, RYE, LENTIL, SESAME SEED, AMARANTH, SOYBEAN, SUGARCANE, 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

Bamboo 9X, 12X, 15X, 30X, Barley 9X, 12X, 15X, 30X, Poppy Seed 9X, 12X, 15X, 30X, Corn 9X, 12X, 15X, 30X, Flax Seed 9X, 12X, 15X, 30X, Buckwheat 9X, 12X, 15X, 30X, Millet 9X, 12X, 15X, 30X, Milo 9X, 12X, 15X, 30X, Oat 9X, 12X, 15X, 30X, Rice 9X, 12X, 15X, 30X, Rye 9X, 12X, 15X, 30X, Lentils 9X, 12X, 15X, 30X, Sesame 9X, 12X, 15X, 30X, Amaranth 9X, 12X, 15X, 30X, Soy Bean 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.

INDICATIONS:

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 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

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 & See Antigens

HOMEOPATHIC

1 FL OZ (30 ml)

Grain and Seed AntigensGrain and Seed Antigens

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0566-12023-06-22C16284748780-1f386c649-b3f8-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0566-12023-01-30C16284748780-1f386c649-b3f8-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0566GRAIN AND SEED ANTIGENS (BAMBOO, BARLEY, POPPY SEED, CORN, FLAX SEED, BUCKWHEAT, MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOY BEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Legacy NDC20230623_9ad306fe-fce4-4de8-8f34-204e7e03abce.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-056643857-0566-1

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
BAMBUSA VULGARIS LEAFEMY54R518CACTIB
BARLEY5PWM7YLI7RACTIB
POPPY SEED60RO23IR87ACTIB
CORN0N8672707OACTIB
FLAX SEED4110YT348CACTIB
BUCKWHEATN0Y68724R3ACTIB
MILLETTJR6B3R47PACTIB
SORGHUM BICOLOR WHOLEY3T98X3AL6ACTIB
OATZ6J799EAJKACTIB
BROWN RICE659G217HPGACTIB
RYE0R4AQI398XACTIB
LENTIL6O38V6B52OACTIB
SESAME SEED7Y1255HVXRACTIB
AMARANTH37RBV3X49KACTIB
SOYBEANL7HT8F1ZODACTIB
SUGARCANE81H2R5AOH3ACTIB
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
26cec7f6-c059-4328-b193-308e6324cb1c9ad306fe-fce4-4de8-8f34-204e7e03abce2023-06-22WarningsExact identifier
spl id: 26cec7f6-c059-4328-b193-308e6324cb1c
spl set id: 9ad306fe-fce4-4de8-8f34-204e7e03abce

Reported adverse events (FAERS/openFDA)#

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