FDA.reportPublic FDA data

OHM-HEP

Manufacturer
OHM PHARMA INC.
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:06

Label at a glance#

ProductOHM-HEP
Active ingredientBERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, CYNARA SCOLYMUS LEAF, TARAXACUM OFFICINALE, VERATRUM ALBUM ROOT
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​ACTIVE INGREDIENTS: 100 ml contains: Berberis Vulgaris 12X, Carduus Marianus 6X, Chelidonium Majus 12X, China Officinalis 7X, Cynara Scolymus 9X, Taraxacum Officinale 7X, Veratrum Album 12X; 0.143 ml each.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves primary and secondary functional hepatic disorders.**

WARNINGS SECTION

​Medicamento Homeopatico.

Venta bajo prescripcion medica.

Mantengase fuera del alcance de niños.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Mantengase fuera del alcance de niños.

DOSAGE & ADMINISTRATION SECTION

​DIRECTIONS: Shake 10 times before use. Adults & children above 12 years of age: spray 3 - 4 times a day or as directed by a health care professional. Children under 12: use half the adult dose.

OTHER SAFETY INFORMATION

​CONDICIONES DE ALMACENAMIENTO: Conservar el producto protegido del calor, luz y humedad. Alcamacenar a no mas de 30°C.

INACTIVE INGREDIENT SECTION

​INACTIVE INGREDIENT:

USP Ethanol Alcohol 15%, Glycerin 15%, Purified Water.

OTC - QUESTIONS SECTION

​Manufactured according to HPUS standards.

Mfg. By: OHM PHARMA INC.

Mineral Wells, Tx 76067

R.S. INVIMA: MH2011-0001768

Importado y Distribuido para

Colombia por:

OHM PHARMA COLOMBIA Ltda.

DG. 39 NO 34 C SUR 30.

Enviado, Antioquia

Tel: (57) 4-379 5995

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​NDC: 66096-756-02

OHM-HEP

Medicamento Homeopatico

Natural - Safe - Effective

No Side Effects - Non Habit Forming

ohm PHARMA

OHM-HEP 1 oz bottle labelOHM-HEP 1 oz bottle label

OTC - PURPOSE SECTION

USES: Temporarily relieves primary and secondary functional hepatic disorders.**

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-756-02OHM-HEP30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-756OHM-HEP (BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHINA OFFICINALIS, CYNARA SCOLYMUS, TARAXACUM OFFICINALE, VERATRUM ALBUM) SPRAY [OHM PHARMA INC.]2Current NDC, Legacy NDC, 1 package rows20210112_e384a684-2899-4c4e-bebb-8d0418fa5b8c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-75666096-756-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CYNARA SCOLYMUS LEAFB71UA545DEACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB

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
OHM-HEPBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHINA OFFICINALIS, CYNARA SCOLYMUS, TARAXACUM OFFICINALE, VERATRUM ALBUMOHM PHARMA INC.e384a684-2899-4c4e-bebb-8d0418fa5b8c2021-01-11WarningsExact identifier
ndc (package): 66096-756-02
ndc (product): 66096-756
ndc11 (package): 66096075602
spl id: b8a7e698-353d-6841-e053-2a95a90ada82
spl set id: e384a684-2899-4c4e-bebb-8d0418fa5b8c

Reported adverse events (FAERS/openFDA)#

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