FDA.reportPublic FDA data

OHM-OST

Manufacturer
OHM PHARMA INC.
Effective date
2021-03-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:28

Label at a glance#

ProductOHM-OST
Active ingredientARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, CAUSTICUM, CINCHONA OFFICINALIS BARK, COLCHICUM AUTUMNALE BULB, SOLANUM DULCAMARA TOP, LEDUM PALUSTRE TWIG, TOXICODENDRON PUBESCENS LEAF, COMFREY ROOT
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (HPUS*): 100 mL contains: Arnica Montana 4X, Calcarea Phosphorica 12X, Causticum 12X, China Officinalis 12X,

Colchicum Autumnale 12X, Dulcamara 6X, Ledum Palustre 7X, Rhus Toxicodendron 12X, Symphytum Officianale 8X; 11.10 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 / Indicacion:Oral administration. Shake 10 times before use. Hold close to mouth and spray under the tongue as directed by a healthcare professional. Via de administracion oral. Agite 10 veces antes de usarlo. Aplique directamente bajo la lengua segun indicacion medica.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

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: 66096-758-02

OHM-OST

Medicamiento Homeopatico

1 fl oz bottle label1 fl oz bottle label

OTC - PURPOSE SECTION

Medicamento Homeopatico

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66096-758-022021-03-25C16284748780-1ba0f9c33-5698-a910-e053-dadaa90a0b85OHM-OST
66096-758-022021-01-29C16284748780-1ba0f9c33-5698-a910-e053-dadaa90a0b85OHM-OST

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-758-02OHM-OST30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-758OHM-OST (ARNICA MONTANA, CALCAREA PHOSPHORICA, CAUSTICUM, CHINA OFFICINALIS, COLCHICUM AUTUMNALE, DULCAMARA, LEDUM PALUSTRE, RHUS TOXICODENDRON, SYMPHYTUM OFFICINALE) SPRAY [OHM PHARMA INC.]2Current NDC, Legacy NDC, 1 package rows20210326_773c7d64-387b-4232-9b4f-93b7ea026efe.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
66096-75866096-758-02

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
ARNICA MONTANAO80TY208ZWACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
CAUSTICUMDD5FO1WKFUACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
COMFREY ROOTM9VVZ08EKQACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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-OSTARNICA MONTANA, CALCAREA PHOSPHORICA, CAUSTICUM, CHINA OFFICINALIS, COLCHICUM AUTUMNALE, DULCAMARA, LEDUM PALUSTRE, RHUS TOXICODENDRON, SYMPHYTUM OFFICINALEOHM PHARMA INC.773c7d64-387b-4232-9b4f-93b7ea026efe2021-03-25WarningsExact identifier
ndc (package): 66096-758-02
ndc (product): 66096-758
ndc11 (package): 66096075802
spl id: 765be013-8d34-47c0-a69d-416ee4325857
spl set id: 773c7d64-387b-4232-9b4f-93b7ea026efe

Reported adverse events (FAERS/openFDA)#

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