FDA.reportPublic FDA data

Biting Insect Antigens

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-06-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:21:24

Label at a glance#

ProductBiting Insect Antigens
Active ingredientAPIS MELLIFERA, HYPERICUM PERFORATUM WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, CIMEX LECTULARIUS, FORMICA RUFA, PULEX IRRITANS, VESPA CRABRO
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

Apis Mellifica 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Cimex Lectularius (Bed Bug) 15X, 30X, Formica Rufa (Red Wood Ants) 15X, 30X, Pulex Irritans (Human Flea) 15X, 30X, Vespa Crabro (Hornet, Wasp) 15X, 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For the relief of allergies due to biting insects.

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

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 the relief of allergies due to biting insects.

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

BITING INSECT ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

BITING INSECT ANTIGENSBITING INSECT ANTIGENS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0263-12023-06-07C16284748780-1f386c649-a386-0266-e053-dadaa90a7c1aDrug Facts
43857-0263-12023-01-30C16284748780-1f386c649-a386-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0263-1Biting Insect Antigens1 mL in 1 BOTTLE, DROPPERLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0263BITING INSECT ANTIGENS (APIS MELLIFICA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, CIMEX LECTULARIUS (BED BUG), FORMICA RUFA (RED WOOD ANTS), PULEX IRRITANS (HUMAN FLEA), VESPA CRABRO (HORNET, WASP)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]6Current NDC, Legacy NDC, 1 package rows20230608_c5f34ec0-fb5a-4922-b785-13badc199afc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z3
CIMEX LECTULARIUSACTIVE INGREDIENTW66P4K3SGW3
FORMICA RUFAACTIVE INGREDIENT55H0W83JO53
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB3
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P3
PULEX IRRITANSACTIVE INGREDIENTL63DD62R8R3
VESPA CRABROACTIVE INGREDIENTK3ALM8S49H3
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z3
CIMEX LECTULARIUSACTIVE MOIETYW66P4K3SGW3
FORMICA RUFAACTIVE MOIETY55H0W83JO53
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB3
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P3
PULEX IRRITANSACTIVE MOIETYL63DD62R8R3
VESPA CRABROACTIVE MOIETYK3ALM8S49H3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-026343857-0263-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
CIMEX LECTULARIUSW66P4K3SGWACTIB
FORMICA RUFA55H0W83JO5ACTIB
PULEX IRRITANSL63DD62R8RACTIB
VESPA CRABROK3ALM8S49HACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Biting Insect AntigensAPIS MELLIFICA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, CIMEX LECTULARIUS (BED BUG), FORMICA RUFA (RED WOOD ANTS), PULEX IRRITANS (HUMAN FLEA), VESPA CRABRO (HORNET, WASP)BioActive Nutritional, Inc.c5f34ec0-fb5a-4922-b785-13badc199afc2023-06-07WarningsExact identifier
ndc (package): 43857-0263-1
ndc (product): 43857-0263
ndc11 (package): 43857026301
spl id: 637b1682-6eb6-4a77-9c8c-4955a7fae96d
spl set id: c5f34ec0-fb5a-4922-b785-13badc199afc

Reported adverse events (FAERS/openFDA)#

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