FDA.reportPublic FDA data

Prostatone

Product NDC
44911-0494
11-digit product format
449110494
Labeler code
44911
Product ID
44911-0494_9b4312a6-561d-4e1e-90f4-ef8f81639b4b
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrangea Arborescens, Sabal Serrulata, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Pareira Brava, Pulsatilla (Pratensis), Thuja Occidentalis, Triticum Occidentalis, Triticum Repens, Staphysagria, Zincum Metallicum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-04-11
Substance
CHIMAPHILA UMBELLATA WHOLE; CHONDRODENDRON TOMENTOSUM ROOT; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; ELYMUS REPENS ROOT; HYDRANGEA ARBORESCENS ROOT; PULSATILLA PRATENSIS; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; ZINC
Active strength
4; 12; 12; 12; 12; 12; 3; 12; 3; 12; 12 [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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHIMAPHILA UMBELLATA WHOLE4 [hp_X]/mL
CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP12 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP12 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
ELYMUS REPENS ROOT12 [hp_X]/mL
HYDRANGEA ARBORESCENS ROOT3 [hp_X]/mL
PULSATILLA PRATENSIS12 [hp_X]/mL
SAW PALMETTO3 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]/mL
ZINC12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWCK21A9W9J, 395A3P448Z, 396421SP9F, Q28R5GF371, 00543AP1JV, 3IXW0F6P8W, SFK828Q2DE, 8E272251DI, J7WWH9M8QS, 1NT28V9397, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0494-12024-10-29C16284748780-1ba0f9c33-5877-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0494-12023-01-30C16284748780-1ba0f9c33-5877-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0494-12021-05-25C16284748780-1ba0f9c33-5877-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0494-12021-01-29C16284748780-1ba0f9c33-5877-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0494-1Prostatone30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0494PROSTATONE (HYDRANGEA ARBORESCENS, SABAL SERRULATA, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, PAREIRA BRAVA, PULSATILLA (PRATENSIS), THUJA OCCIDENTALIS, TRITICUM OCCIDENTALIS, TRITICUM REPENS, STAPHYSAGRIA, ZINCUM METALLICUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20241031_0e6da80d-a294-4b04-b266-77a6ab0f0603.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0494-14491104940130 mL in 1 BOTTLE, DROPPER (44911-0494-1) 30 ml2019-04-110000-00-00NoNoCurrent