MedPath

N12

N12

Approved
Approval ID

0c54fc72-792f-0b9b-e063-6394a90ac2f0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

Apex Energetics Inc.

DUNS: 195816384

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, SUS SCROFA BONE MARROW, BRYONIA ALBA ROOT, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, OLEA EUROPAEA FLOWER, ULEX EUROPAEUS, FLOWER, LACHESIS MUTA VENOM, LEVISTICUM OFFICINALE, TREPONEMIC SKIN CANKER HUMAN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63479-1412
Product Classification
G
Generic Name
ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, SUS SCROFA BONE MARROW, BRYONIA ALBA ROOT, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, OLEA EUROPAEA FLOWER, ULEX EUROPAEUS, FLOWER, LACHESIS MUTA VENOM, LEVISTICUM OFFICINALE, TREPONEMIC SKIN CANKER HUMAN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (27)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SULFURActive
Quantity: 30 [hp_X] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
SUS SCROFA SPLEENActive
Quantity: 7 [hp_C] in 1 mL
Code: 92AMN5J79Y
Classification: ACTIB
OLEA EUROPAEA FLOWERActive
Quantity: 30 [hp_X] in 1 mL
Code: 498M34P1VZ
Classification: ACTIB
TUBERCULIN PURIFIED PROTEIN DERIVATIVEActive
Quantity: 30 [hp_X] in 1 mL
Code: I7L8FKN87J
Classification: ACTIB
STAPHYLOCOCCUS SIMULANSActive
Quantity: 30 [hp_X] in 1 mL
Code: V68E0X60VL
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 30 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
ULEX EUROPAEUS FLOWERActive
Quantity: 30 [hp_X] in 1 mL
Code: 398DBS1PXN
Classification: ACTIB
GONORRHEAL URETHRAL SECRETION HUMANActive
Quantity: 30 [hp_X] in 1 mL
Code: 9BZG9E3I8F
Classification: ACTIB
BILBERRYActive
Quantity: 30 [hp_X] in 1 mL
Code: 9P2U39H18W
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 30 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
ECHINACEA PURPUREAActive
Quantity: 9 [hp_X] in 1 mL
Code: QI7G114Y98
Classification: ACTIB
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGENActive
Quantity: 30 [hp_X] in 1 mL
Code: 4SV59689SK
Classification: ACTIB
TREPONEMIC SKIN CANKER HUMANActive
Quantity: 30 [hp_X] in 1 mL
Code: 4ZWP7FWI8W
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 30 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
BAPTISIA TINCTORIA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: 5EF0HWI5WU
Classification: ACTIB
LEVISTICUM OFFICINALEActive
Quantity: 12 [hp_X] in 1 mL
Code: SZD8739PH1
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STAPHYLOCOCCUS HAEMOLYTICUSActive
Quantity: 30 [hp_X] in 1 mL
Code: 092IJ99835
Classification: ACTIB
VISCUM ALBUM FRUITING TOPActive
Quantity: 12 [hp_X] in 1 mL
Code: BK9092J5MP
Classification: ACTIB
STREPTOCOCCUS PYOGENESActive
Quantity: 30 [hp_X] in 1 mL
Code: LJ2LP0YL98
Classification: ACTIB
RANCID BEEFActive
Quantity: 30 [hp_X] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHIActive
Quantity: 60 [hp_X] in 1 mL
Code: 760T5R8B3O
Classification: ACTIB
STAPHYLOCOCCUS EPIDERMIDISActive
Quantity: 30 [hp_X] in 1 mL
Code: D5T403TNGE
Classification: ACTIB
SUS SCROFA BONE MARROWActive
Quantity: 7 [hp_C] in 1 mL
Code: VP2CN2G7Y8
Classification: ACTIB
ECHINACEA ANGUSTIFOLIAActive
Quantity: 9 [hp_X] in 1 mL
Code: VB06AV5US8
Classification: ACTIB
LACHESIS MUTA VENOMActive
Quantity: 30 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/15/2024

FUTUREPLEX® N12

ANTITOX®

IMMUNOSODE™

Homeopathic Formula

Fatigue* Headaches*

Cough*

1 fl oz (30 mL)

Alcohol 20% by Volume

N12

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/15/2024

Uses:

For temporary relief of minor:

fatigue*

headache*

cough*

swollen tonsils*

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/15/2024

Active Ingredients

Arsenicum Album

6X 9X 12X 15X 30X

Baptisia Tinctoria

4X 6X 9X 12X 15X

Bone Marrow Suis

4C 7C

Bryonia

6X 8X 12X 15X 20X 30X

Echinacea Angustifolia

3X 6X 9X

Echinacea Purpurea

3X 6X 9X

European Olive Flower

12X 20X 30X

Gorse Flower

12X 20X 30X

Lachesis Mutus

6X 8X 10X 12X 15X 30X

Levisticum Officinale

3X 6X 9X 12X

Luesinum

12X 15X 20X 30X

Medorrhinum

30X

Pyrogenium

12X 15X 20X 30X

Staphylococcus Epidermidis

12X 15X 20X 30X

Staphylococcus Haemolyticus

12X 15X 20X 30X

Staphylococcus Simulans

12X 15X 20X 30X

Streptococcinum

12X 15X 20X 30X

Sulphur

6X 9X 12X 15X 20X 30X

Sus Scrofa Spleen

4C 7C

Thuja Occidentalis

6X 9X 12X 15X 20X 30X

Tuberculinum

12X 15X 20X 30X

Typhoid Vaccine

12X 15X 18X 20X 30X 60X

Vaccininum

14X 20X 30X

Vaccinium Myrtillus

30X

Viscum Album Fruiting Top

3X 5X 8X 10X 12X

WARNINGS SECTION

LOINC: 34071-1Updated: 1/15/2024

Warnings:

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

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

**Keep out of reach of children.**In case of overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if fatigue, headaches, cough, swollen tonsils, or other symptoms do not improve within 7 days or are accompanied by fever.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/2/2021

Directions:

Adults & children ages 12 years and over: Take 10 drops under the tongue 3-4 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/2/2021

Inactive Ingredients

alcohol (20% by volume), distilled water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/2/2021

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

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N12 - FDA Drug Approval Details