FDA.reportPublic FDA data

Category II

Product NDC
64616-083
11-digit product format
646160083
Labeler code
64616
Product ID
64616-083_462f42f0-0e03-0acc-e063-6294a90ab8fc
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
ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; CHASTE TREE; ERIODICTYON CALIFORNICUM LEAF; EUPHORBIA RESINIFERA RESIN; GAMBOGE; LEAD; LYCOSA TARANTULA; MERCURIC CHLORIDE; MERCURIC CYANIDE; MERCURIC IODIDE; MERCURY; PAEONIA OFFICINALIS ROOT; PINE TAR; SELENIUM; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT
Active strength
6; 6; 3; 3; 14; 7; 10; 15; 10; 15; 10; 10; 15; 10; 15; 6; 10 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARALIA RACEMOSA ROOT6 [hp_X]/mL
ARUNDO PLINIANA ROOT6 [hp_X]/mL
CHASTE TREE3 [hp_X]/mL
ERIODICTYON CALIFORNICUM LEAF3 [hp_X]/mL
EUPHORBIA RESINIFERA RESIN14 [hp_X]/mL
GAMBOGE7 [hp_X]/mL
LEAD10 [hp_X]/mL
LYCOSA TARANTULA15 [hp_X]/mL
MERCURIC CHLORIDE10 [hp_X]/mL
MERCURIC CYANIDE15 [hp_X]/mL
MERCURIC IODIDE10 [hp_X]/mL
MERCURY10 [hp_X]/mL
PAEONIA OFFICINALIS ROOT15 [hp_X]/mL
PINE TAR10 [hp_X]/mL
SELENIUM15 [hp_X]/mL
THYROID, UNSPECIFIED6 [hp_C]/mL
TRILLIUM ERECTUM ROOT10 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT90W4582DU, ZXE7LB03WC, 433OSF3U8A, 2Y7TIQ135H, 1TI1O9028K, 7556HJ7587, 2P299V784P, 86M454L2TT, 53GH7MZT1R, RWG7BD1032, R03O05RB0P, FXS1BY2PGL, 8R564U2E1P, YFH4WC535J, H6241UJ22B, 0B4FDL9I6P, AHW6F0T2X0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-083-02Category II59 mL in 1 BOTTLE, DROPPERLIQUID599

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARALIA RACEMOSA ROOTACTIVE INGREDIENTT90W4582DUCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ARUNDO PLINIANA ROOTACTIVE INGREDIENTZXE7LB03WCCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
CHASTE TREEACTIVE INGREDIENT433OSF3U8ACATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ERIODICTYON CALIFORNICUM LEAFACTIVE INGREDIENT2Y7TIQ135HCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
EUPHORBIA RESINIFERA RESINACTIVE INGREDIENT1TI1O9028KCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
GAMBOGEACTIVE INGREDIENT7556HJ7587CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
LEADACTIVE INGREDIENT2P299V784PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
LYCOSA TARANTULAACTIVE INGREDIENT86M454L2TTCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1RCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURIC CYANIDEACTIVE INGREDIENTRWG7BD1032CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURIC IODIDEACTIVE INGREDIENTR03O05RB0PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURYACTIVE INGREDIENTFXS1BY2PGLCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
PAEONIA OFFICINALIS ROOTACTIVE INGREDIENT8R564U2E1PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
PINE TARACTIVE INGREDIENTYFH4WC535JCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
SELENIUMACTIVE INGREDIENTH6241UJ22BCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
THYROID, UNSPECIFIEDACTIVE INGREDIENT0B4FDL9I6PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
TRILLIUM ERECTUM ROOTACTIVE INGREDIENTAHW6F0T2X0CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ARALIA RACEMOSA ROOTACTIVE MOIETYT90W4582DUCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ARUNDO PLINIANA ROOTACTIVE MOIETYZXE7LB03WCCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
CHASTE TREEACTIVE MOIETY433OSF3U8ACATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ERIODICTYON CALIFORNICUM LEAFACTIVE MOIETY2Y7TIQ135HCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
EUPHORBIA RESINIFERA RESINACTIVE MOIETY1TI1O9028KCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
GAMBOGEACTIVE MOIETY7556HJ7587CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
LEADACTIVE MOIETY2P299V784PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
LYCOSA TARANTULAACTIVE MOIETY86M454L2TTCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURIC CATIONACTIVE MOIETYED30FJ8Y42CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURIC CYANIDEACTIVE MOIETYRWG7BD1032CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURIC IODIDEACTIVE MOIETYR03O05RB0PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
MERCURYACTIVE MOIETYFXS1BY2PGLCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
PAEONIA OFFICINALIS ROOTACTIVE MOIETY8R564U2E1PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
PINE TARACTIVE MOIETYYFH4WC535JCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
SELENIUMACTIVE MOIETYH6241UJ22BCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
THYROID, UNSPECIFIEDACTIVE MOIETY0B4FDL9I6PCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
TRILLIUM ERECTUM ROOTACTIVE MOIETYAHW6F0T2X0CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-083CATEGORY II (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]8Current NDC, Legacy NDC, 1 package rows20241212_325579ef-0a34-4cdb-b9b9-44b8d300bece.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-083-026461600830259 mL in 1 BOTTLE, DROPPER (64616-083-02) 59 ml2013-03-200000-00-00NoNoCurrent