FDA.reportPublic FDA data

OHM-DETL

Manufacturer
OHM PHARMA INC.
Effective date
2020-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:12:24

Label at a glance#

ProductOHM-DETL
Active ingredientPEUMUS BOLDUS LEAF, MILK THISTLE, CHELIDONIUM MAJUS WHOLE, CINCHONA OFFICINALIS BARK, CYNARA SCOLYMUS LEAF, GOLDENSEAL, STRYCHNOS NUX-VOMICA SEED, TIN, TARAXACUM OFFICINALE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (HPUS*): Each 100 mL contains: Boldo 5X, Carduus Marianus 5X,
Chelidonium Majus 5X, China Officinalis 7X, Cynara Scolymus 5X, Hydrastis Canadensis 5X, Nux
Vomica 7X, Stannum Metallicum 16X, Taraxacum Officinale 5X; 3.30 mL each.


*The letters “HPUS” indicate the components in the product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.

INDICATIONS & USAGE SECTION

Contraindicaciones: Ninguna reportada

WARNINGS SECTION

Advertencias: Venta bajo prescripción médica, mantengase fuera del alcance de los niños. No
utilizar si el sello de seguridad del spray esta roto. Mantener el medicamento protegido del calor,
luz y humedad, almacenar a no más de 30°C.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Mantengase fuera del alcance de los niños

DOSAGE & ADMINISTRATION SECTION

Directions/Indicación: Oral administration. Shake 10 times before use. Hold close to mouth
and spray under the tongue as directed by a healthcare professional. Vía de administración oral.
Agite 10 veces antes de usarlo. Aplique directamente bajo la lengua según indicación médica.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Ethanol Alcohol USP 15%, Glycerin USP 10%, Purified Water.

OTHER SAFETY INFORMATION

Lote y fecha de vencimiento: Ver en la parte inferior del envase

OTC - QUESTIONS SECTION

R.S. INVIMA: MH2010-0001591
Importado y Distribuido para Colombia por: OHM PHARMA COLOMBIA S.A.S.
Bodega 5, Km 23, Vereda Don Diego, El Retiro, Antioquia, Tel (57-4) 322 8761.

Mfg. By : OHM PHARMA, Inc.
Mineral Wells, TX 76067 USA
www.ohmpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 66096-719-02

OHM-DETL

ohm 

PHARMA

1 fl oz (30 mL)

1 oz bottle label1 oz bottle label

1 oz bottle label1 oz bottle label

OTC - PURPOSE SECTION

Medicamento Homeopático

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-719-02OHM-DETL30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-719OHM-DETL (BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHINA OFFICINALIS, CYNARA SCOLYMUS, HYDRASTIS CANADENSIS, NUX VOMICA, STANNUM METALLICUM, TARAXACUM OFFICINALE) SPRAY [OHM PHARMA INC.]2Current NDC, Legacy NDC, 1 package rows20200219_e806ec02-ad9b-426b-ac11-c4ee90ef1c43.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
66096-71966096-719-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CYNARA SCOLYMUS LEAFB71UA545DEACTIB
GOLDENSEALZW3Z11D0JVACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
TIN387GMG9FH5ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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