FDA.reportPublic FDA data

Damiana Complex

Manufacturer
OHM PHARMA INC.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:30

Label at a glance#

ProductDamiana Complex
Active ingredientCHASTE TREE, AVENA SATIVA FLOWERING TOP, TURNERA DIFFUSA LEAFY TWIG, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SUS SCROFA TESTICLE, PHOSPHORIC ACID, SAW PALMETTO, SELENIUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Agnes Castus 3X, Avena Sativa 3X, Damiana 3X, Gelsemium Sempervirens 12X, Ignatia Amara 12X, Lycopodium Clavatum 12X, Orchitinum 12X, Phosphoricum Acidum 12X, Sabal Serrulata 3X, Selenium Metallicum 12X.

​*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves low stamina.**

** ​Claims based on traditional homepathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS SECTION

WARNINGS: IF PREGNANT OR BREAST- FEEDING, ask a health professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • ​KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Shake 10 times before use. Adults: spray 3 times under the tongue 2-3 times a day or as directed by a health care professional. Not for use by children.

OTHER SAFETY INFORMATION

Do not use if cap seal is broken.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethanol Alcohol 15% (non-GMO, Kosher Certified, Cane, Gluten, Allergen Free), Vegetable Glycerin 15%, Purified Water.

OTC - QUESTIONS SECTION

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC MEDICINE

NDC: 66096-726-05

DAMIANA Complex

Natural - Safe - Effective

No Side Effects

2 fl oz (59 mL) / 15% Alcohol

PRODUCT OF USA

2oz bottle label2oz bottle label

OTC - PURPOSE SECTION

Temporarily relieves low stamina.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-726-05Damiana Complex59 mL in 1 BOTTLE, SPRAYLIQUID594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-726DAMIANA COMPLEX (AGNES CASTUS, AVENA SATIVA, DAMIANA, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, LYCOPODIUM CLAVATUM, ORCHITINUM, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SELENIUM METALLICUM.) LIQUID [OHM PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20211230_e1bf2bd7-dddf-40e2-bfe2-b907af36996a.zip

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
66096-72666096-726-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CHASTE TREE433OSF3U8AACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SUS SCROFA TESTICLEKM02613O28ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SELENIUMH6241UJ22BACTIB

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
Damiana ComplexAGNES CASTUS, AVENA SATIVA, DAMIANA, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, LYCOPODIUM CLAVATUM, ORCHITINUM, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SELENIUM METALLICUM.OHM PHARMA INC.e1bf2bd7-dddf-40e2-bfe2-b907af36996a2021-12-29WarningsExact identifier
ndc (package): 66096-726-05
ndc (product): 66096-726
ndc11 (package): 66096072605
spl id: d44ad692-3331-29f3-e053-2a95a90acbf8
spl set id: e1bf2bd7-dddf-40e2-bfe2-b907af36996a

Reported adverse events (FAERS/openFDA)#

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