FDA.reportPublic FDA data

MALE-PROS

Product NDC
64616-098
11-digit product format
646160098
Labeler code
64616
Product ID
64616-098_462ed6ff-206e-5519-e063-6394a90a2a29
Type
HUMAN OTC DRUG
Nonproprietary name
Prostrate Booster
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-04-08
Substance
ACTAEA SPICATA ROOT; ANTIMONY TRISULFIDE; ARNICA MONTANA; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; KEROSENE; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; OCIMUM AMERICANUM LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SILVER NITRATE; VERATRUM ALBUM ROOT; ZINC OXIDE
Active strength
10; 9; 7; 6; 15; 14; 20; 10; 7; 14; 12; 15; 70; 15; 6; 6 [hp_X]/mL; [hp_C]/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
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MALE-PROS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTAEA SPICATA ROOT10 [hp_X]/mL
ANTIMONY TRISULFIDE9 [hp_C]/mL
ARNICA MONTANA7 [hp_X]/mL
CHELIDONIUM MAJUS6 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP15 [hp_X]/mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT14 [hp_X]/mL
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE20 [hp_X]/mL
KEROSENE10 [hp_X]/mL
LEDUM PALUSTRE TWIG7 [hp_X]/mL
MERCURIC CYANIDE14 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
OCIMUM AMERICANUM LEAF15 [hp_X]/mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM70 [hp_X]/mL
SILVER NITRATE15 [hp_X]/mL
VERATRUM ALBUM ROOT6 [hp_X]/mL
ZINC OXIDE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FU86L9OS0, F79059A38U, O80TY208ZW, 7E889U5RNN, 396421SP9F, 21Y9GZ1LZA, IQV54TN60Y, 1C89KKC04E, 877L01IZ0P, RWG7BD1032, 324Y4038G2, 4EX119B76E, 36XQ854NWW, 95IT3W8JZE, QNS6W5US1Z, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-098-02MALE-PROS59 mL in 1 BOTTLE, DROPPERLIQUID599

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTAEA SPICATA ROOTACTIVE INGREDIENT3FU86L9OS0MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38UMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNNMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9FMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE INGREDIENT21Y9GZ1LZAMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICEACTIVE INGREDIENTIQV54TN60YMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
KEROSENEACTIVE INGREDIENT1C89KKC04EMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
MERCURIC CYANIDEACTIVE INGREDIENTRWG7BD1032MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
OCIMUM AMERICANUM LEAFACTIVE INGREDIENT4EX119B76EMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE INGREDIENT36XQ854NWWMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZEMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
VERATRUM ALBUM ROOTACTIVE INGREDIENTQNS6W5US1ZMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ACTAEA SPICATA ROOTACTIVE MOIETY3FU86L9OS0MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ANTIMONY TRISULFIDEACTIVE MOIETYF79059A38UMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNNMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9FMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE MOIETY21Y9GZ1LZAMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICEACTIVE MOIETYIQV54TN60YMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
KEROSENEACTIVE MOIETY1C89KKC04EMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
MERCURIC CYANIDEACTIVE MOIETYRWG7BD1032MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
OCIMUM AMERICANUM LEAFACTIVE MOIETY4EX119B76EMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE MOIETY36XQ854NWWMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
SILVER CATIONACTIVE MOIETY57N7B0K90AMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
VERATRUM ALBUM ROOTACTIVE MOIETYQNS6W5US1ZMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-098MALE-PROS (PROSTRATE BOOSTER) LIQUID [VITALITY WORKS, INC.]8Current NDC, Legacy NDC, 1 package rows20241212_3d456306-2d27-4509-b3bd-f4f8b81cf98d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-098-026461600980259 mL in 1 BOTTLE, DROPPER (64616-098-02) 59 ml2013-04-080000-00-00NoNoCurrent