FDA.reportPublic FDA data

N09

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:22

Label at a glance#

ProductN09 BACTEROTOX
Active ingredientSILICON DIOXIDE, ONION, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, LACHESIS MUTA VENOM, FERROSOFERRIC PHOSPHATE, GOLDENSEAL, ACONITUM NAPELLUS, GARLIC, ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, THUJA OCCIDENTALIS LEAFY TWIG, CALCIUM SULFATE ANHYDROUS
Label structure7 sections

Dosage and administration

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Aconitum Napellus

30X 60X 200X

Allium Cepa

2X 30X

Allium Sativum

2X 30X

Belladonna

3X 200X

Calcarea Sulphurica

12X 30X 60X

Calendula Officinalis

1X

Echinacea Angustifolia

1X

Ferrum Phosphoricum

9X 30X 60X

Hepar Sulphuris Calcareum

12X 30X 200X

Hydrastis Canadensis

1X

Lachesis Mutus

9X 12X 15X 30X 60X 90X

Myristica Sebifera

2X

Silicea

10X 12X

Thuja Occidentalis

9X 12X 15X 30X 60X 90X

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

swollen glands*

congestion*

diarrhea*

sore throat*

cough*

chill and heat*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTHER SAFETY INFORMATION

Do not use if clear seal over the cap is broken or missing.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if swollen glands, congestion, diarrhea, sore throat, cough, chill and heat, or other symptoms do not improve within 7 days or are accompanied by fever.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), glycerin, distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® N09

ANTITOX®

BACTEROTOX™

Homeopathic Formula

Swollen Glands*

Congestion*

Diarrhea*

1 fl oz (30 mL)

Alcohol 20% by Volume

N0921-0409N0921-0409

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1409-1N09BACTEROTOX30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1409N09 BACTEROTOX (ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALIS) SOLUTION/ DROPS [APEX ENERGETICS INC.]3Current NDC, Legacy NDC, 1 package rows20240110_ba99bb1e-c36f-8bf8-e053-2995a90ac308.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-140963479-1409-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ONION492225Q21HACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GOLDENSEALZW3Z11D0JVACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
GARLICV1V998DC17ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
VIROLA SEBIFERA RESINGHJ5XX5SGSACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB

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
N09 BACTEROTOXACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.ba99bb1e-c36f-8bf8-e053-2995a90ac3082024-01-08WarningsExact identifier
ndc (package): 63479-1409-1
ndc (product): 63479-1409
ndc11 (package): 63479140901
spl id: 0e773c6a-0172-fae5-e063-6294a90af595
spl set id: ba99bb1e-c36f-8bf8-e053-2995a90ac308

Reported adverse events (FAERS/openFDA)#

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