FDA.reportPublic FDA data

Edema

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:28:14

Label at a glance#

ProductEdema HP
Active ingredientAPIS MELLIFERA, ARSENIC TRIOXIDE, DIGITALIS, IRON, LYCOPODIUM CLAVATUM SPORE, TOXICODENDRON PUBESCENS LEAF, SAMBUCUS NIGRA FLOWERING TOP, STROPHANTHUS HISPIDUS SEED
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 30X, Arsenicum Album 30X, Digitalis Purpurea 30X, Ferrum Metallicum 30X, Lycopodium Clavatum 30X, Rhus Tox 30X, Sambucus Nigra 30X, Strophanthus Hispidus 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms of swelling of the extremities.

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 temporary relief of symptoms of swelling of the extremities.

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

EDEMA-HP

HOMEOPATHIC

1 FL OZ (30 ml)

Edema-HPEdema-HP

Edema-HPEdema-HP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0299-12024-10-17C16284748780-19d75b9d0-20e6-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0299-12022-01-28C16284748780-19d75b9d0-20e6-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0299-12020-04-22C16284748780-19d75b9d0-20e6-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0299-12020-01-31C16284748780-19d75b9d0-20e6-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0299-1EdemaHP30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0299EDEMA HP (APIS MELLIFICA, ARSENICUM ALBUM, DIGITALIS PURPUREA, FERRUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20241019_420be173-18b9-41f1-b826-835214078bb5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z2
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO2
DIGITALISACTIVE INGREDIENTF1T8QT9U8B2
IRONACTIVE INGREDIENTE1UOL152H72
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4792
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18U2
STROPHANTHUS HISPIDUS SEEDACTIVE INGREDIENTMO892VI77K2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A2
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z2
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV2
DIGITALISACTIVE MOIETYF1T8QT9U8B2
IRONACTIVE MOIETYE1UOL152H72
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4792
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18U2
STROPHANTHUS HISPIDUS SEEDACTIVE MOIETYMO892VI77K2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
43857-029943857-0299-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
DIGITALISF1T8QT9U8BACTIB
IRONE1UOL152H7ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
STROPHANTHUS HISPIDUS SEEDMO892VI77KACTIB
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
Edema HPAPIS MELLIFICA, ARSENICUM ALBUM, DIGITALIS PURPUREA, FERRUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SAMBUCUS NIGRA, STROPHANTHUS HISPIDUSBioActive Nutritional, Inc.420be173-18b9-41f1-b826-835214078bb52024-10-17WarningsExact identifier
ndc (package): 43857-0299-1
ndc (product): 43857-0299
ndc11 (package): 43857029901
spl id: 777359e4-f8c6-466f-93b0-c32775d74822
spl set id: 420be173-18b9-41f1-b826-835214078bb5

Reported adverse events (FAERS/openFDA)#

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