FDA.reportPublic FDA data

BAC

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2021-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:25:11

Label at a glance#

ProductBAC
Active ingredientECHINACEA ANGUSTIFOLIA, LOMATIUM DISSECTUM ROOT, MYRRH, NASTURTIUM OFFICINALE, TABEBUIA IMPETIGINOSA BARK, GOLDENSEAL, PROPOLIS WAX, SUS SCROFA ADRENAL GLAND, SUS SCROFA LYMPH, SUS SCROFA SPLEEN, SUS SCROFA THYMUS, SUS SCROFA THYROID, ARSENIC TRIOXIDE, ATROPA BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, BOTULINUM TOXIN TYPE A, ESCHERICHIA COLI, PROTEUS VULGARIS, PSEUDOMONAS AERUGINOSA, PROTEUS MORGANII, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI, CLOSTRIDIUM PERFRINGENS
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, Lomatium Dissectum 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Glandula Suprarenalis Suis 8X, Lymph Node (Suis) 8X, Spleen (Suis) 8X, Thymus (Suis) 8X, Thyroidinum (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Hypericum Perforatum 12X, Phosphorus 12X, Botulinum 30X, 60X, Escherichia Coli 30X, 60X, Proteus (Vulgaris) 30X, 60X, Pseudomonas Aeruginosa 30X, 60X, Proteus (Morgani) 30X, 60X, Salmonella Typhi Nosode 33X, 60X, Clostridium Perfringens 15C, 30C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fever, sore throat and acute irritation of the bladder.

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 fever, sore throat and acute irritation of the bladder.

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
BAC
HOMEOPATHIC
1 FL OZ (30 ml)

BACBAC

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0530-12021-12-01C16284748780-1ba0f9c33-2bb4-a910-e053-dadaa90a0b85Drug Facts:
43857-0530-12021-01-29C16284748780-1ba0f9c33-2bb4-a910-e053-dadaa90a0b85Drug Facts:

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-053043857-0530-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
MYRRHJC71GJ1F3LACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
GOLDENSEALZW3Z11D0JVACTIB
PROPOLIS WAX6Y8XYV2NOFACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA LYMPH33A7VYU29LACTIB
SUS SCROFA SPLEEN92AMN5J79YACTIB
SUS SCROFA THYMUS7B69B0BD62ACTIB
SUS SCROFA THYROID6RV024OAUQACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
PHOSPHORUS27YLU75U4WACTIB
BOTULINUM TOXIN TYPE AE211KPY694ACTIB
ESCHERICHIA COLI514B9K0L10ACTIB
PROTEUS VULGARIS11T9HCO30OACTIB
PSEUDOMONAS AERUGINOSAY793W5V55NACTIB
PROTEUS MORGANII56X6LID5ZYACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI760T5R8B3OACTIB
CLOSTRIDIUM PERFRINGENSOVP6XX033EACTIB
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
ffdca3ab-76e7-440e-b1c5-9e93bf2e91c252b26f6f-8a26-4d27-926a-0b3c1ee2a2682021-12-01WarningsExact identifier
spl id: ffdca3ab-76e7-440e-b1c5-9e93bf2e91c2
spl set id: 52b26f6f-8a26-4d27-926a-0b3c1ee2a268

Reported adverse events (FAERS/openFDA)#

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