Category IV

Product NDC
64616-085
11-digit product format
646160085
Labeler code
64616
Product ID
64616-085_462efdaf-fea9-a564-e063-6294a90aeaf6
Type
HUMAN OTC DRUG
Nonproprietary name
Immune System Booster
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-03-20
Substance
ACTAEA SPICATA ROOT; ALOE; COPPER; CUPRIC ARSENITE; FRAXINUS AMERICANA BARK; LYTTA VESICATORIA; SKIM MILK; SOLANUM DULCAMARA TOP; URTICA URENS; ZINC
Active strength
6; 7; 10; 15; 8; 7; 20; 5; 5; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Category IV
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTAEA SPICATA ROOT6 [hp_X]/mL
ALOE7 [hp_X]/mL
LYTTA VESICATORIA10 [hp_X]/mL
CUPRIC ARSENITE15 [hp_X]/mL
COPPER8 [hp_X]/mL
SOLANUM DULCAMARA TOP7 [hp_X]/mL
SKIM MILK20 [hp_X]/mL
FRAXINUS AMERICANA BARK5 [hp_X]/mL
URTICA URENS5 [hp_X]/mL
ZINC20 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FU86L9OS0Internal UNII lookup
V5VD430YW9Internal UNII lookup
3Q034RO3BTInternal UNII lookup
SK8L60BCSQInternal UNII lookup
789U1901C5Internal UNII lookup
KPS1B1162NInternal UNII lookup
6A001Y4M5AInternal UNII lookup
0B24UR1O1SInternal UNII lookup
IHN2NQ5OF9Internal UNII lookup
J41CSQ7QDSInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
790a1b3e-2b5e-426c-9c43-8674c59c9ce1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-085-02Category IV59 mL in 1 BOTTLE, DROPPERLIQUID599

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTAEA SPICATA ROOTACTIVE INGREDIENT3FU86L9OS0CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ALOEACTIVE INGREDIENTV5VD430YW9CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
COPPERACTIVE INGREDIENT789U1901C5CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CUPRIC ARSENITEACTIVE INGREDIENTSK8L60BCSQCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
FRAXINUS AMERICANA BARKACTIVE INGREDIENT0B24UR1O1SCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SKIM MILKACTIVE INGREDIENT6A001Y4M5ACATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162NCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF9CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ZINCACTIVE INGREDIENTJ41CSQ7QDSCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ACTAEA SPICATA ROOTACTIVE MOIETY3FU86L9OS0CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ALOEACTIVE MOIETYV5VD430YW9CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
COPPERACTIVE MOIETY789U1901C5CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CUPRIC CATIONACTIVE MOIETY8CBV67279LCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
FRAXINUS AMERICANA BARKACTIVE MOIETY0B24UR1O1SCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SKIM MILKACTIVE MOIETY6A001Y4M5ACATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162NCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
URTICA URENSACTIVE MOIETYIHN2NQ5OF9CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ZINCACTIVE MOIETYJ41CSQ7QDSCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-085CATEGORY IV (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]8Current NDC, Legacy NDC, 1 package rows20241212_790a1b3e-2b5e-426c-9c43-8674c59c9ce1.zip

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 IVIMMUNE SYSTEM BOOSTERVitality Works, Inc.790a1b3e-2b5e-426c-9c43-8674c59c9ce12025-12-17WarningsExact identifier
ndc (product): 64616-085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-085-026461600850259 mL in 1 BOTTLE, DROPPER (64616-085-02) 59 ml2013-03-200000-00-00NoNoCurrent