FDA.reportPublic FDA data

Category III

Product NDC
64616-084
11-digit product format
646160084
Labeler code
64616
Product ID
64616-084_462effa1-836c-6fc2-e063-6394a90a3bcf
Type
HUMAN OTC DRUG
Nonproprietary name
Immune System Booster
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-03-13
Substance
ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; CHIONANTHUS VIRGINICUS BARK; CORALLIUM RUBRUM EXOSKELETON; EGG PHOSPHOLIPIDS; GOLD; MORELLA CERIFERA ROOT BARK; ORNITHOGALUM UMBELLATUM; PETROSELINUM CRISPUM; SANGUINARIA CANADENSIS ROOT
Active strength
12; 10; 10; 9; 7; 15; 15; 10; 7; 10; 10; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL12 [hp_X]/mL
ARSENIC TRIIODIDE10 [hp_X]/mL
ARSENIC TRIOXIDE10 [hp_X]/mL
ARTEMISIA VULGARIS ROOT9 [hp_X]/mL
CHIONANTHUS VIRGINICUS BARK7 [hp_X]/mL
CORALLIUM RUBRUM EXOSKELETON15 [hp_X]/mL
EGG PHOSPHOLIPIDS15 [hp_X]/mL
GOLD10 [hp_X]/mL
MORELLA CERIFERA ROOT BARK7 [hp_X]/mL
ORNITHOGALUM UMBELLATUM10 [hp_X]/mL
PETROSELINUM CRISPUM10 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT10 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, 3029988O2T, S7V92P67HO, 32MP823R8S, 2CA71K0DLE, 1Z74184RGV, 79Y1949PYO, S46HJ3710D, 9NS3M2Y78S, 1WZA4Y92EX, N9288CD508

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H10CATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARSENIC TRIIODIDEACTIVE INGREDIENT3029988O2TCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARTEMISIA VULGARIS ROOTACTIVE INGREDIENT32MP823R8SCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CHIONANTHUS VIRGINICUS BARKACTIVE INGREDIENTS9Y4B22U2ECATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CORALLIUM RUBRUM EXOSKELETONACTIVE INGREDIENT2CA71K0DLECATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
EGG PHOSPHOLIPIDSACTIVE INGREDIENT1Z74184RGVCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
GOLDACTIVE INGREDIENT79Y1949PYOCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
MORELLA CERIFERA ROOT BARKACTIVE INGREDIENTS46HJ3710DCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ORNITHOGALUM UMBELLATUMACTIVE INGREDIENT9NS3M2Y78SCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
PETROSELINUM CRISPUMACTIVE INGREDIENT1WZA4Y92EXCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD508CATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H10CATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARTEMISIA VULGARIS ROOTACTIVE MOIETY32MP823R8SCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CHIONANTHUS VIRGINICUS BARKACTIVE MOIETYS9Y4B22U2ECATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CORALLIUM RUBRUM EXOSKELETONACTIVE MOIETY2CA71K0DLECATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
EGG PHOSPHOLIPIDSACTIVE MOIETY1Z74184RGVCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
GOLDACTIVE MOIETY79Y1949PYOCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
MORELLA CERIFERA ROOT BARKACTIVE MOIETYS46HJ3710DCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ORNITHOGALUM UMBELLATUMACTIVE MOIETY9NS3M2Y78SCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
PETROSELINUM CRISPUMACTIVE MOIETY1WZA4Y92EXCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD508CATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-084CATEGORY III (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC.]8Current NDC, Legacy NDC, 1 package rows20241212_ce663db6-b893-4510-a139-7de851c3ea87.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-084-026461600840259 mL in 1 BOTTLE, DROPPER (64616-084-02) 59 ml2013-03-200000-00-00NoNoCurrent