FDA.reportPublic FDA data

Category III

Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:36:16

Label at a glance#

ProductCategory III
Active ingredientEGG PHOSPHOLIPIDS, MORELLA CERIFERA ROOT BARK, ORNITHOGALUM UMBELLATUM, PETROSELINUM CRISPUM, SANGUINARIA CANADENSIS ROOT, ARSENIC TRIOXIDE, ARSENIC TRIIODIDE, ARTEMISIA VULGARIS ROOT, GOLD, ACTIVATED CHARCOAL, CHIONANTHUS VIRGINICUS BARK, CORALLIUM RUBRUM EXOSKELETON
Label structure8 sections

Label contents#

Full prescribing information#

Category III

OTC - ACTIVE INGREDIENT SECTION

Arsenicum Album 10X                         Corallium Rubrum 15X

Arsenicum Iodatum 8X                        Lecithin 10X

Artemisea Vulagaris 7X                       Myrica Cerifera 7X

Aurum Metallicum 10X                         Ornithogalum Umbellatum 10X

Carbo Vegetabilis 12X                         Pertoselinum Sativum 10X

Chionanthus Virginica 7X                    Sanguinaria Canadensis 7X

Category III

INACTIVE INGREDIENT SECTION

Alcohol, Purified Water

Category III

WARNINGS SECTION

Use only under the direction of a health care professional. Do not use if tamper evident seal is broken or missing.

Category III

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Category III

INDICATIONS & USAGE SECTION

For the temporary relief of headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

Category III

DOSAGE & ADMINISTRATION SECTION

Orally 25 drops, per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

Category III

OTC - PURPOSE SECTION

Temporarely eases headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

Category III

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-084-02Category III59 mL in 1 BOTTLE, DROPPERLIQUID599

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H101
ARSENIC TRIIODIDEACTIVE INGREDIENT3029988O2T1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ARTEMISIA VULGARIS ROOTACTIVE INGREDIENT32MP823R8S1
CHIONANTHUS VIRGINICUS BARKACTIVE INGREDIENTS9Y4B22U2E1
CORALLIUM RUBRUM EXOSKELETONACTIVE INGREDIENT2CA71K0DLE1
EGG PHOSPHOLIPIDSACTIVE INGREDIENT1Z74184RGV1
GOLDACTIVE INGREDIENT79Y1949PYO1
MORELLA CERIFERA ROOT BARKACTIVE INGREDIENTS46HJ3710D1
ORNITHOGALUM UMBELLATUMACTIVE INGREDIENT9NS3M2Y78S1
PETROSELINUM CRISPUMACTIVE INGREDIENT1WZA4Y92EX1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H101
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
ARTEMISIA VULGARIS ROOTACTIVE MOIETY32MP823R8S1
CHIONANTHUS VIRGINICUS BARKACTIVE MOIETYS9Y4B22U2E1
CORALLIUM RUBRUM EXOSKELETONACTIVE MOIETY2CA71K0DLE1
EGG PHOSPHOLIPIDSACTIVE MOIETY1Z74184RGV1
GOLDACTIVE MOIETY79Y1949PYO1
MORELLA CERIFERA ROOT BARKACTIVE MOIETYS46HJ3710D1
ORNITHOGALUM UMBELLATUMACTIVE MOIETY9NS3M2Y78S1
PETROSELINUM CRISPUMACTIVE MOIETY1WZA4Y92EX1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-08464616-084-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
EGG PHOSPHOLIPIDS1Z74184RGVACTIB
MORELLA CERIFERA ROOT BARKS46HJ3710DACTIB
ORNITHOGALUM UMBELLATUM9NS3M2Y78SACTIB
PETROSELINUM CRISPUM1WZA4Y92EXACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
ARSENIC TRIIODIDE3029988O2TACTIB
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB
GOLD79Y1949PYOACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
CORALLIUM RUBRUM EXOSKELETON2CA71K0DLEACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Category IIIIMMUNE SYSTEM BOOSTERVitality Works, Inc.ce663db6-b893-4510-a139-7de851c3ea872025-12-17WarningsExact identifier
ndc (package): 64616-084-02
ndc (product): 64616-084
ndc11 (package): 64616008402
spl id: 462effa1-836c-6fc2-e063-6394a90a3bcf
spl set id: ce663db6-b893-4510-a139-7de851c3ea87

Reported adverse events (FAERS/openFDA)#

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