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 UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FU86L9OS0Internal UNII lookup
46883LR90EInternal UNII lookup
6X68976407Internal UNII lookup
4D7G21HDBCInternal UNII lookup
O9M1UQ4YIOInternal UNII lookup
4WRK2153H3Internal UNII lookup
T4423S18FMInternal UNII lookup
1C4QK22F9JInternal UNII lookup
RU45X2JN0ZInternal UNII lookup
CI71S98N1ZInternal UNII lookup
AK7JF626KXInternal UNII lookup
1PIP394IIDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cbb330b-b541-457b-9a97-e17a5837d30dAvailable on FDA.report

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

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 (product): 64616-082

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