FDA.reportPublic FDA data

Category I

Manufacturer
Vitality Works, Inc | Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:36:04

Label at a glance#

ProductCategory I
Active ingredientACTAEA SPICATA ROOT, ANAGALLIS ARVENSIS, ARGEMONE MEXICANA, CANDIDA ALBICANS, HELODERMA HORRIDUM VENOM, HYOSCYAMUS NIGER, POTASSIUM DICHROMATE, POTASSIUM IODIDE, POTASSIUM NITRATE, POTASSIUM PHOSPHATE, DIBASIC, SENNA LEAF, SPONGIA OFFICINALIS SKELETON, ROASTED
Label structure8 sections

Label contents#

Full prescribing information#

Category I

OTC - ACTIVE INGREDIENT SECTION

Actaea Spicata 6X                           Kali Bichromicum 6X, 10X

Anagallis Arvensis 6X                      Kali Iodatum 8X, 10X

Argemone Mexicana 15X                 Kali Nitricum 8X, 10X

Candida Albicans 14X, 17X              Kali Phosphoricum 8X, 10X

Heloderma 14X                               Senna 7X

Hyoscyamus Niger 5X                     Spongia Tosta 10X, 15X

Category I

INACTIVE INGREDIENT SECTION

Alcohol, Purified Water,

Category I

WARNINGS SECTION

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

Category I

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Category I

INDICATIONS & USAGE SECTION

For the temporary relief of general systemic malise, flu and cold symptoms and achiness.

Category I

DOSAGE & ADMINISTRATION SECTION

Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult.

Category I

OTC - PURPOSE SECTION

Temporarily eases malaise, flu and cold symptoms and aches.

Category I

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-082-02Category I59 mL in 1 BOTTLE, DROPPERLIQUID5911

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACTAEA SPICATA ROOTACTIVE INGREDIENT3FU86L9OS01
ANAGALLIS ARVENSISACTIVE INGREDIENT46883LR90E1
ARGEMONE MEXICANAACTIVE INGREDIENT6X689764071
CANDIDA ALBICANSACTIVE INGREDIENT4D7G21HDBC1
HELODERMA HORRIDUM VENOMACTIVE INGREDIENTO9M1UQ4YIO1
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H31
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM1
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J1
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0Z1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
SENNA LEAFACTIVE INGREDIENTAK7JF626KX1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IID1
ACTAEA SPICATA ROOTACTIVE MOIETY3FU86L9OS01
ANAGALLIS ARVENSISACTIVE MOIETY46883LR90E1
ARGEMONE MEXICANAACTIVE MOIETY6X689764071
CANDIDA ALBICANSACTIVE MOIETY4D7G21HDBC1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2V1
HELODERMA HORRIDUM VENOMACTIVE MOIETYO9M1UQ4YIO1
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H31
IODIDE IONACTIVE MOIETY09G4I6V86Q1
NITRATE IONACTIVE MOIETYT93E9Y28441
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR1
SENNA LEAFACTIVE MOIETYAK7JF626KX1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IID1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
64616-08264616-082-02

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
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ACTAEA SPICATA ROOT3FU86L9OS0ACTIB
ANAGALLIS ARVENSIS46883LR90EACTIB
ARGEMONE MEXICANA6X68976407ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
HELODERMA HORRIDUM VENOMO9M1UQ4YIOACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
SENNA LEAFAK7JF626KXACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB

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 IIMMUNE SYSTEM BOOSTERVitality Works, Inc1cbb330b-b541-457b-9a97-e17a5837d30d2025-12-17WarningsExact identifier
ndc (package): 64616-082-02
ndc (product): 64616-082
ndc11 (package): 64616008202
spl id: 462efc33-321d-a6e4-e063-6294a90abcc5
spl set id: 1cbb330b-b541-457b-9a97-e17a5837d30d

Reported adverse events (FAERS/openFDA)#

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