FDA.reportPublic FDA data

Prostate

Product NDC
43742-0705
11-digit product format
437420705
Labeler code
43742
Product ID
43742-0705_77aeb389-9888-41bc-9e98-340ee75de2d5
Type
HUMAN OTC DRUG
Nonproprietary name
Petroselinum Sativum, Populus Tremuloides, Sabal Serrulata, Chimaphila Umbellata, Adenosinum Triphosphoricum Dinatrum, Equol, Kreosotum, Nadidum, Testosterone, Prostate (Suis), Succinicum Acidum, Hepar Sulphuris Calcareum, Conium Maculatum, Proteus (Mirabilis), Proteus (Vulgaris)
Dosage form
LIQUID
Route
ORAL
Labeler
Deseret Biologicals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-02-17
Marketing end
2028-04-24
Substance
PETROSELINUM CRISPUM; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; SAW PALMETTO; CHIMAPHILA UMBELLATA; ADENOSINE TRIPHOSPHATE DISODIUM; EQUOL, (+/-)-; WOOD CREOSOTE; NADIDE; TESTOSTERONE; SUS SCROFA PROSTATE; SUCCINIC ACID; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; PROTEUS MIRABILIS; PROTEUS VULGARIS
Active strength
4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 8; 8; 10; 30; 30; 30 [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; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Current FDA listing
Yes

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
Prostate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROSELINUM CRISPUM4 [hp_X]/mL
POPULUS TREMULOIDES BARK4 [hp_X]/mL
POPULUS TREMULOIDES LEAF4 [hp_X]/mL
SAW PALMETTO4 [hp_X]/mL
CHIMAPHILA UMBELLATA5 [hp_X]/mL
ADENOSINE TRIPHOSPHATE DISODIUM6 [hp_X]/mL
EQUOL, (+/-)-6 [hp_X]/mL
WOOD CREOSOTE6 [hp_X]/mL
NADIDE6 [hp_X]/mL
TESTOSTERONE6 [hp_X]/mL
SUS SCROFA PROSTATE8 [hp_X]/mL
SUCCINIC ACID8 [hp_X]/mL
CALCIUM SULFIDE10 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP30 [hp_X]/mL
PROTEUS MIRABILIS30 [hp_C]/mL
PROTEUS VULGARIS30 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1WZA4Y92EXInternal UNII lookup
5543O0CEIDInternal UNII lookup
7IIH57D9E0Internal UNII lookup
J7WWH9M8QSInternal UNII lookup
WCK21A9W9JInternal UNII lookup
5L51B4DR1GInternal UNII lookup
2RZ8A7D0E8Internal UNII lookup
3JYG22FD73Internal UNII lookup
0U46U6E8UKInternal UNII lookup
3XMK78S47OInternal UNII lookup
O6UD3347K2Internal UNII lookup
AB6MNQ6J6LInternal UNII lookup
1MBW07J51QInternal UNII lookup
Q28R5GF371Internal UNII lookup
C177VR41DVInternal UNII lookup
11T9HCO30OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0aeda42e-c703-4fb8-857d-52705d681f68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-0705-1Prostate30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-0705PROSTATE (PETROSELINUM SATIVUM, POPULUS TREMULOIDES, SABAL SERRULATA, CHIMAPHILA UMBELLATA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, EQUOL, KREOSOTUM, NADIDUM, TESTOSTERONE, PROSTATE (SUIS), SUCCINICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, CONIUM MACULATUM, PROTEUS (MIRABILIS), PROTEUS (VULGARIS)) LIQUID [DESERET BIOLOGICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20231013_0aeda42e-c703-4fb8-857d-52705d681f68.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
ProstatePETROSELINUM SATIVUM, POPULUS TREMULOIDES, SABAL SERRULATA, CHIMAPHILA UMBELLATA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, EQUOL, KREOSOTUM, NADIDUM, TESTOSTERONE, PROSTATE (SUIS), SUCCINICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, CONIUM MACULATUM, PROTEUS (MIRABILIS), PROTEUS (VULGARIS)Deseret Biologicals, Inc.0aeda42e-c703-4fb8-857d-52705d681f682023-10-12WarningsExact identifier
ndc (product): 43742-0705

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43742-0705-14374207050130 mL in 1 BOTTLE, DROPPER (43742-0705-1) 30 ml2016-02-172028-04-24NoNoCurrent