FDA.reportPublic FDA data

Category I

Product NDC
64616-082
11-digit product format
646160082
Labeler code
64616
Product ID
64616-082_462efc33-321d-a6e4-e063-6294a90abcc5
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; 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
Active strength
6; 6; 15; 17; 14; 5; 10; 10; 10; 10; 7; 15 [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], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [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 I
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTAEA SPICATA ROOT6 [hp_X]/mL
ANAGALLIS ARVENSIS6 [hp_X]/mL
ARGEMONE MEXICANA15 [hp_X]/mL
CANDIDA ALBICANS17 [hp_X]/mL
HELODERMA HORRIDUM VENOM14 [hp_X]/mL
HYOSCYAMUS NIGER5 [hp_X]/mL
POTASSIUM DICHROMATE10 [hp_X]/mL
POTASSIUM IODIDE10 [hp_X]/mL
POTASSIUM NITRATE10 [hp_X]/mL
POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]/mL
SENNA LEAF7 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FU86L9OS0, 46883LR90E, 6X68976407, 4D7G21HDBC, O9M1UQ4YIO, 4WRK2153H3, T4423S18FM, 1C4QK22F9J, RU45X2JN0Z, CI71S98N1Z, AK7JF626KX, 1PIP394IID

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTAEA SPICATA ROOTACTIVE INGREDIENT3FU86L9OS0CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ANAGALLIS ARVENSISACTIVE INGREDIENT46883LR90ECATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ARGEMONE MEXICANAACTIVE INGREDIENT6X68976407CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
CANDIDA ALBICANSACTIVE INGREDIENT4D7G21HDBCCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
HELODERMA HORRIDUM VENOMACTIVE INGREDIENTO9M1UQ4YIOCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H3CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9JCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
SENNA LEAFACTIVE INGREDIENTAK7JF626KXCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IIDCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ACTAEA SPICATA ROOTACTIVE MOIETY3FU86L9OS0CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ANAGALLIS ARVENSISACTIVE MOIETY46883LR90ECATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ARGEMONE MEXICANAACTIVE MOIETY6X68976407CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
CANDIDA ALBICANSACTIVE MOIETY4D7G21HDBCCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2VCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
HELODERMA HORRIDUM VENOMACTIVE MOIETYO9M1UQ4YIOCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H3CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
IODIDE IONACTIVE MOIETY09G4I6V86QCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
NITRATE IONACTIVE MOIETYT93E9Y2844CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
SENNA LEAFACTIVE MOIETYAK7JF626KXCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IIDCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1
WaterINACTIVE INGREDIENT059QF0KO0RCATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-082CATEGORY I (IMMUNE SYSTEM BOOSTER) LIQUID [VITALITY WORKS, INC]10Current NDC, Legacy NDC, 1 package rows20241212_1cbb330b-b541-457b-9a97-e17a5837d30d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-082-026461600820259 mL in 1 BOTTLE, DROPPER (64616-082-02) 59 ml2013-04-160000-00-00NoNoCurrent