Prostatone

Product NDC
44911-0311
Requested package NDC
44911-0311-1
11-digit product format
449110311
Labeler code
44911
Product ID
44911-0311_50bc34c8-0465-4277-b6bf-7366590145b4
Type
HUMAN OTC DRUG
Nonproprietary name
Chimaphila Umbellata, Hydrangea Arborescens, Sabal Serrulata, 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
2015-12-11
Marketing end
2022-08-14
Substance
CHIMAPHILA UMBELLATA; HYDRANGEA ARBORESCENS ROOT; SAW PALMETTO; 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 [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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage44911-031144911-0311-1DDiscontinued by firm2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0311-12020-04-08C16284748780-19d75b9d0-d645-f424-e053-dadaa90a57ceDrug Facts:
44911-0311-12020-01-31C16284748780-19d75b9d0-d645-f424-e053-dadaa90a57ceDrug Facts:

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0311-14491103110130 mL in 1 BOTTLE, DROPPER (44911-0311-1) 30 ml2015-12-112022-08-14NoNoCurrent