FDA.reportPublic FDA data

N01

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:31

Label at a glance#

ProductN01 PROTOMER
Active ingredientEPINEPHRINE, SILVER NITRATE, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARNICA MONTANA, SARSAPARILLA, GOLD, CHELIDONIUM MAJUS, NICKEL, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG, SOLIDAGO VIRGAUREA FLOWERING TOP, ZINC VALERATE DIHYDRATE, CALCIUM SULFIDE, SODIUM FLUORIDE, QUININE ARSENITE, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA TOP
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

Adrenalinum

4C

Argentum Nitricum

6X 9X 12X 15X

Arnica Montana

3X 12X

Aurum Metallicum

12X 15X 20X 30X

Avena Sativa

1X

Berberis Vulgaris

1X

Chelidonium Majus

1X

Chininum Arsenicosum

4X 6X 8X 12X

Hepar Sulphuris Calcareum

8X 10X 12X

Hypericum Perforatum

3X

Natrum Fluoratum

6X 8X 10X 12X

Niccolum Metallicum

12X 15X

Passiflora Incarnata

1X

Sarsaparilla

2X

Silicea

10X 12X 15X 20X

Solidago Virgaurea

1X

Thuja Occidentalis

6X 9X 12X

Zincum Valerianicum

6X 9X 12X

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

irritability*

headache*

sadness*

recurrent nausea*

vomiting*

fear*

*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 irritability, headache, sadness, recurrent nausea, vomiting, fear, 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), distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® N01

ANTITOX®

PROTOMER™

Homeopathic Formula

Irritability*

Headache* Sadness*

1 fl oz (30 mL)

Alcohol 20% by Volume

N0121-0423N0121-0423

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1401-1N01PROTOMER30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1401N01 PROTOMER (ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bfc8e049-2f62-31c4-e053-2a95a90a6e16.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-140163479-1401-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINEYKH834O4BHACTIB
SILVER NITRATE95IT3W8JZEACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
ARNICA MONTANAO80TY208ZWACTIB
SARSAPARILLA2H1576D5WGACTIB
GOLD79Y1949PYOACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
NICKEL7OV03QG267ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
CALCIUM SULFIDE1MBW07J51QACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
QUININE ARSENITE42QO5P0NLMACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
PASSIFLORA INCARNATA TOPCLF5YFS11OACTIB

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
N01 PROTOMERADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUMApex Energetics Inc.bfc8e049-2f62-31c4-e053-2a95a90a6e162024-01-08WarningsExact identifier
ndc (package): 63479-1401-1
ndc (product): 63479-1401
ndc11 (package): 63479140101
spl id: 0e77063c-fc41-cee6-e063-6394a90a0d54
spl set id: bfc8e049-2f62-31c4-e053-2a95a90a6e16

Reported adverse events (FAERS/openFDA)#

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