FDA.reportPublic FDA data

Testosterone

Manufacturer
Liddell Laboratories, Inc.
Effective date
2012-02-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:03:34

Label at a glance#

ProductTestosterone
Active ingredientAVENA SATIVA FLOWERING TOP, SILYBUM MARIANUM SEED, TURNERA DIFFUSA LEAFY TWIG, GALIUM APARINE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ASIAN GINSENG, POPULUS TREMULOIDES BARK, TESTOSTERONE, THUJA OCCIDENTALIS LEAFY TWIG, BEEF LIVER, NUPHAR LUTEUM ROOT, BOS TAURUS TESTICLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:Avena sativa 1X, Carduus marianus 1X, Damiana 1X, Galium aparine 3X, Hamamelis virginiana 1X, Hepar bovinum 6X, Korean ginseng 1X, Nuphar luteum 2X, Orchitinum bovinum 6X, Populus tremuloides 1X, Testosterone 30X, Thuja occidentalis 200C.

OTC - PURPOSE SECTION

INDICATIONS:  Temporarily supports the body to rebalance testosterone output.  Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

WARNINGS SECTION

WARNINGS:  Not for use on children.  If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician.  Insomnia may be a symptom of a serious underlying medical illness.

As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

TAMPER EVIDENT: There is a seal around the neck of the bottle.  Do not use if this seal is broken or missing.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:  Adults:  Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day.  Some people notice improvement within two or three weeks, others take longer.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:  Organic alcohol 30% v/v, Purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

INDICATIONS:  Temporarily supports the body to rebalance testosterone output.  Symptoms may include:  poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.

OTC - QUESTIONS SECTION

Distributed By ProBLEN

(888) 326-2121, www.problen.com

2850 Shoreline Trail

Rockwall, TX 75032

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Testosterone

HOMEOPATHIC

ORGANOTHERAPY

1 FL OZ (30ML)

proBLEN

TestosteroneTestosterone

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0113-32019-11-13C16284748780-197449f38-cafa-f6ea-e053-dbdaa90aa703Testosterone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0113-1Testosterone30 mL in 1 BOTTLE, SPRAYSPRAY302
50845-0113-2Testosterone1 in 1 CARTONSPRAY12
50845-0113-3Testosterone1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0113TESTOSTERONE (AVENA SATIVA, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR BOVINUM, KOREAN GINSENG, NUPHAR LUTEUM, ORCHITINUM BOVINUM,) SPRAY [LIDDELL LABORATORIES, INC.]2Legacy NDC, 3 package rows20120224_8b6fabf1-d249-4990-990f-8e8ad8175b12.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASIAN GINSENGACTIVE INGREDIENTCUQ3A77YXI2
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F2
BEEF LIVERACTIVE INGREDIENTW8N8R550222
BOS TAURUS TESTICLEACTIVE INGREDIENTPR4RXL6G2H2
GALIUM APARINEACTIVE INGREDIENTZ4B65614882
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS2
NUPHAR LUTEUM ROOTACTIVE INGREDIENT714LIU3V6D2
POPULUS TREMULOIDES BARKACTIVE INGREDIENT5543O0CEID2
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE2
TESTOSTERONEACTIVE INGREDIENT3XMK78S47O2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93972
TURNERA DIFFUSA LEAFY TWIGACTIVE INGREDIENTRQ2CFA7WWJ2
ASIAN GINSENGACTIVE MOIETYCUQ3A77YXI2
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F2
BEEF LIVERACTIVE MOIETYW8N8R550222
BOS TAURUS TESTICLEACTIVE MOIETYPR4RXL6G2H2
GALIUM APARINEACTIVE MOIETYZ4B65614882
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS2
NUPHAR LUTEUM ROOTACTIVE MOIETY714LIU3V6D2
POPULUS TREMULOIDES BARKACTIVE MOIETY5543O0CEID2
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE2
TESTOSTERONEACTIVE MOIETY3XMK78S47O2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93972
TURNERA DIFFUSA LEAFY TWIGACTIVE MOIETYRQ2CFA7WWJ2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-011350845-0113-1, 50845-0113-2, 50845-0113-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
SILYBUM MARIANUM SEEDU946SH95EEACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
GALIUM APARINEZ4B6561488ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ASIAN GINSENGCUQ3A77YXIACTIB
POPULUS TREMULOIDES BARK5543O0CEIDACTIB
TESTOSTERONE3XMK78S47OACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BEEF LIVERW8N8R55022ACTIB
NUPHAR LUTEUM ROOT714LIU3V6DACTIB
BOS TAURUS TESTICLEPR4RXL6G2HACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
ab1db44b-9486-46f6-bb00-0fb3c26a946b8b6fabf1-d249-4990-990f-8e8ad8175b122012-02-23WarningsExact identifier
spl id: ab1db44b-9486-46f6-bb00-0fb3c26a946b
spl set id: 8b6fabf1-d249-4990-990f-8e8ad8175b12

Reported adverse events (FAERS/openFDA)#

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