Home NDC 44911-0494-1 Prostatone
Product NDC 44911-0494
Requested package NDC 44911-0494-1
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 HYDRANGEA ARBORESCENS ROOT; SAW PALMETTO; CHIMAPHILA UMBELLATA WHOLE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA PRATENSIS; THUJA OCCIDENTALIS LEAFY TWIG; ELYMUS REPENS ROOT; DELPHINIUM STAPHISAGRIA SEED; ZINC
Active strength 3; 3; 4; 12; 12; 12; 12; 12; 12; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Prostatone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRANGEA ARBORESCENS ROOT 3 [hp_X]/mL SAW PALMETTO 3 [hp_X]/mL CHIMAPHILA UMBELLATA WHOLE 4 [hp_X]/mL CLEMATIS RECTA FLOWERING TOP 12 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP 12 [hp_X]/mL CHONDRODENDRON TOMENTOSUM ROOT 12 [hp_X]/mL PULSATILLA PRATENSIS 12 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/mL ELYMUS REPENS ROOT 12 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/mL ZINC 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0494-1 Prostatone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0494 PROSTATONE (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.] 3 Current NDC, Legacy NDC, 1 package rows 20241031_0e6da80d-a294-4b04-b266-77a6ab0f0603.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prostatone HYDRANGEA ARBORESCENS, SABAL SERRULATA, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, PAREIRA BRAVA, PULSATILLA (PRATENSIS), THUJA OCCIDENTALIS, TRITICUM OCCIDENTALIS, TRITICUM REPENS, STAPHYSAGRIA, ZINCUM METALLICUM Energique, Inc. 0e6da80d-a294-4b04-b266-77a6ab0f0603 2024-10-29 Warnings Exact identifier ndc (package): 44911-0494-1 ndc (product): 44911-0494 ndc11 (package): 44911049401
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0494-1 44911049401 30 mL in 1 BOTTLE, DROPPER (44911-0494-1) 30 ml 2019-04-11 0000-00-00 No No Current