FDA.reportPublic FDA data

OHM IMMUNOLOGICAL ACUTE TERRAIN

Manufacturer
OHM PHARMA INC.
Effective date
2016-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:28

Label at a glance#

ProductOHM IMMUNOLOGICAL ACUTE TERRAIN
Active ingredientACONITUM NAPELLUS, ARANEUS DIADEMATUS, ARNICA MONTANA, CYNANCHUM VINCETOXICUM ROOT, BAPTISIA TINCTORIA, BRYONIA ALBA ROOT, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, CALCIUM SULFIDE, JUGLANS REGIA LEAF, PHYTOLACCA AMERICANA ROOT, SANGUINARIA CANADENSIS ROOT, SMILAX REGELII ROOT, SULFUR, ZINC
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Aconitum Napellus 7X, Aranea Diadema 9X, Arnica Montana 6X, Asclepias Vincetoxicum 12X, Baptisia Tinctoria 8X, Bryonia Alba 10X, Echinacea Angustifolia 6X, Equisetum Hyemale 7X, Eupatorium Perforiatum 10X, Gelsemium Sempervirens 8X, Hepar Sulphuris Calcareum 12X, Juglans Regia 6X, Phytolacca Decandra 10X, Sanguinaria Canadensis 8X, Sarsaparilla 9X, Sulphur 10X, Zincum Metallicum 12X.

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

USES: Temporarily relieves weak immune system response in acute pathologies. Improves acute immune responsiveness.**

SPL UNCLASSIFIED SECTION

**This statement has not been evaluated by the FDA.
It is based on documented Homeopathic Materia Medica.

WARNINGS SECTION

WARNINGS:

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: To open ampoule snap top up and away from you. Using pipette place entire content under the tongue, hold it for 30 seconds and swallow.

POSOLOGY: Adults and children over 12 years: In acute conditions: 1 ampoule every 12 hours. In chronic conditions: 1 ampoule one to four times per week, or as directed by a health professional.

Children under 12 years use 1/2 the adult dose.

Discard unused solution. Solution does not contain any preservatives.

Not for injection.

OTHER SAFETY INFORMATION

OTHER INFORMATION: Store at controlled room temperature. Tamper evident seal. Do not use if box seal is missing or broken.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Isotonic sodium chloride solution.

OTC - QUESTIONS SECTION

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

Made in USA

www.ohmpharma.com

OTC - PURPOSE SECTION

Weak immune system response relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 66096-186-06

OHM IMMUNOLOGICAL ACUTE TERRAIN

HOMEOPATHIC MEDICINE

Pharmaceutical Grade. Professional use only.

CONTENTS: 12 oral ampoules of 2.2 ml each.

Terrain box label englishTerrain box label english

Terrain box label spanishTerrain box label spanish

Ampoule labelAmpoule label

Insert EnglishInsert English

Insert SpanishInsert Spanish

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66096-186-062020-01-31C16284748780-19d75b9cf-fcfb-f424-e053-dadaa90a57ceOHM IMMUNOLOGICAL ACUTE TERRAIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-186-06OHM IMMUNOLOGICAL ACUTE TERRAIN2.2 mL in 1 AMPULELIQUID2.21
66096-186-06OHM IMMUNOLOGICAL ACUTE TERRAIN12 in 1 BOXLIQUID121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-186OHM IMMUNOLOGICAL ACUTE TERRAIN (ACONITUM NAPELLUS, ARANEA DIADEMA, ARNICA MONTANA, ASCLEPIAS VINCETOXICUM, BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, EUPATORIUM PERFORLIATUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, JUGLANS REGIA, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SARSAPARILLA, SULPHUR, ZINCUM METALLICUM) LIQUID [OHM PHARMA INC.]1Legacy NDC, 2 package rows20160112_983bb133-3e21-4eaf-aeec-2ec86594b513.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
66096-18666096-186-06

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
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARANEUS DIADEMATUS6T6CO7R3Z5ACTIB
ARNICA MONTANAO80TY208ZWACTIB
CYNANCHUM VINCETOXICUM ROOT9R858U917WACTIB
BAPTISIA TINCTORIA5K1UO2888YACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
EQUISETUM HYEMALE59677RXH25ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SMILAX REGELII ROOT2H1576D5WGACTIB
SULFUR70FD1KFU70ACTIB
ZINCJ41CSQ7QDSACTIB
SODIUM CHLORIDE451W47IQ8XIACT

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
03b6f067-2073-4b55-82eb-8f25020cee90983bb133-3e21-4eaf-aeec-2ec86594b5132016-01-11WarningsExact identifier
spl id: 03b6f067-2073-4b55-82eb-8f25020cee90
spl set id: 983bb133-3e21-4eaf-aeec-2ec86594b513

Reported adverse events (FAERS/openFDA)#

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