FDA.reportPublic FDA data

Inflammation

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:33:36

Label at a glance#

ProductInflammation I
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, NASTURTIUM OFFICINALE, PHYTOLACCA AMERICANA ROOT, GOLDENSEAL, APIS MELLIFERA, ATROPA BELLADONNA, FERROSOFERRIC PHOSPHATE, NITRIC ACID, NERIUM OLEANDER LEAF, SILICON DIOXIDE
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

Echinacea (Angustifolia) 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 12X, Silicea 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

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.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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 swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

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

INFLAMMATION I

HOMEOPATHIC

1 FL OZ (30 ml)

Inflammation IInflammation I

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0470-1InflammationI30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0470INFLAMMATION I (ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20250521_ddfad5cd-c928-42c0-9562-9feebb73a2cb.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-047043857-0470-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
GOLDENSEALZW3Z11D0JVACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
NITRIC ACID411VRN1TV4ACTIB
NERIUM OLEANDER LEAF7KV510R6H6ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
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
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.ddfad5cd-c928-42c0-9562-9feebb73a2cb2025-05-19WarningsExact identifier
ndc (package): 43857-0470-1
ndc (product): 43857-0470
ndc11 (package): 43857047001
spl id: 13b7abaf-08ed-40ec-ba1e-f18f666c0c0d
spl set id: ddfad5cd-c928-42c0-9562-9feebb73a2cb

Reported adverse events (FAERS/openFDA)#

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