FDA.reportPublic FDA data

OHM RESPIRATORY LOWER TERRAIN

Manufacturer
OHM PHARMA INC.
Effective date
2016-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:28

Label at a glance#

ProductOHM RESPIRATORY LOWER TERRAIN
Active ingredientACONITUM NAPELLUS, ARANEUS DIADEMATUS, BRYONIA ALBA ROOT, EQUISETUM HYEMALE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GOLDENSEAL, JUGLANS REGIA LEAF, POTASSIUM DICHROMATE, PHOSPHORUS, SMILAX REGELII ROOT, SULFUR
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Aconitum 6X, Aranea 9X, Bryonia 6X, Equisetum 7X, Eupatorium Perf 5X, Hydrastis7X, Juglans Reg 6X, Kali Bic 12X, Phosphorus 7X, Sarsaparrilla 9X, Sulphur 8X.

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 lower respiratory track mucosa irritation or secretion due to diverse etiology.**

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, consult a physician. A persistent cough may be a sign of a serious condition. If cough persists for more than 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

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

Acute or chronic functional ailments of the kidneys and/or urinary track relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 66096-172-06

OHM RESPIRATORY LOWER TERRAIN

HOMEOPATHIC MEDICINE

Pharmaceutical Grade. Professional use only.

CONTENTS: 12 oral ampoules of 2.2 ml each.

Terrain Box EnglishTerrain Box English

Terrain Box SpanishTerrain Box Spanish

Ampoule BoxAmpoule Box

Insert EnglishInsert English

Insert SpanishInsert Spanish

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130366096016241GTIN-13: 0366096016241
EAN-13: 0366096016241
GTIN-12: 366096016241
UPC-A: 366096016241
GTIN storage (14 digits): 00366096016241		ampoule box insert spanish.jpg, ampoule box insert english.jpg
BarcodeEAN-130366096172060GTIN-13: 0366096172060
EAN-13: 0366096172060
GTIN-12: 366096172060
UPC-A: 366096172060
GTIN storage (14 digits): 00366096172060		OHM Respiratory Lower Terrain Label.jpg, OHM-RESB.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66096-172-062020-01-31C16284748780-19d75b9cf-d094-f424-e053-dadaa90a57ceOHM RESPIRATORY LOWER TERRAIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-172-06OHM RESPIRATORY LOWER TERRAIN12 in 1 BOXLIQUID121
66096-172-06OHM RESPIRATORY LOWER TERRAIN2.2 mL in 1 AMPULELIQUID2.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-172OHM RESPIRATORY LOWER TERRAIN (ACONITUM, ARANEA, BRYONIA, EQUISETUM, EUPATORIUM PERF, HYDRASTIS, JUGLANS REG, KALI BIC, PHOSPHORUS, SARSAPARRILLA, SULPHUR) LIQUID [OHM PHARMA INC.]1Legacy NDC, 2 package rows20160112_9c93d74e-7ac3-4570-afe0-74f743778cc6.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-17266096-172-06

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
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARANEUS DIADEMATUS6T6CO7R3Z5ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EQUISETUM HYEMALE59677RXH25ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GOLDENSEALZW3Z11D0JVACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
PHOSPHORUS27YLU75U4WACTIB
SMILAX REGELII ROOT2H1576D5WGACTIB
SULFUR70FD1KFU70ACTIB
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
6580d1db-c2b8-4140-8280-9dbbcb89217d9c93d74e-7ac3-4570-afe0-74f743778cc62016-01-12WarningsExact identifier
spl id: 6580d1db-c2b8-4140-8280-9dbbcb89217d
spl set id: 9c93d74e-7ac3-4570-afe0-74f743778cc6

Reported adverse events (FAERS/openFDA)#

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