FDA.reportPublic FDA data

Prostate

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2023-10-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:22:34

Label at a glance#

ProductProstate
Active ingredientPETROSELINUM 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
Label structure9 sections

Dosage and administration

1-10 drops under the tongue, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Petroselinum Sativum 4X, Populus Tremuloides 4X, Sabal Serrulata 4X, Chimaphila Umbellata 5X, Adenosinum Triphosphoricum Dinatrum 6X, Equol 6X, Kreosotum 6X, Nadidum 6X, Testosterone 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Prostate (Suis) 8X, Succinicum Acidum 8X, Hepar Sulphuris Calcareum 10X, Conium Maculatum 30X, Proteus (Mirabilis) 30C, Proteus (Vulgaris) 30C.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of the symptoms of prostate issues including weak stream and frequent urination.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of the symptoms of prostate issues including weak stream and frequent urination.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESBIO

NDC 43742-0705-1

HOMEOPATHIC

PROSTATE

1 FL OZ (30 ml)

ProstateProstate

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-070543742-0705-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROSELINUM CRISPUM1WZA4Y92EXACTIB
POPULUS TREMULOIDES BARK5543O0CEIDACTIB
POPULUS TREMULOIDES LEAF7IIH57D9E0ACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
CHIMAPHILA UMBELLATAWCK21A9W9JACTIB
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GACTIB
EQUOL, (+/-)-2RZ8A7D0E8ACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
NADIDE0U46U6E8UKACTIB
TESTOSTERONE3XMK78S47OACTIB
SUS SCROFA PROSTATEO6UD3347K2ACTIB
SUCCINIC ACIDAB6MNQ6J6LACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
PROTEUS MIRABILISC177VR41DVACTIB
PROTEUS VULGARIS11T9HCO30OACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 (package): 43742-0705-1
ndc (product): 43742-0705
ndc11 (package): 43742070501
spl id: 77aeb389-9888-41bc-9e98-340ee75de2d5
spl set id: 0aeda42e-c703-4fb8-857d-52705d681f68

Reported adverse events (FAERS/openFDA)#

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