FDA.reportPublic FDA data

Cochlearia officinalis

Manufacturer
Washington Homeopathic Products
Effective date
2013-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:39

Label at a glance#

ProductCochlearia officinalis
Active ingredientCOCHLEARIA OFFICINALIS FLOWERING TOP
Label structure8 sections

Indications and uses

To relieve the symptoms of radiating stomach pains.

Dosage and administration

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

COCHLEARIA OFF

USES

OTC - PURPOSE SECTION

To relieve the symptoms of radiating stomach pains.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

INDICATIONS

INDICATIONS & USAGE SECTION

Indications:

COCHLEARIA OFF   Radiating stomach pains

STOP USE AND ASK DOCTOR

WARNINGS SECTION

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose/Lactose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The OTC potency range of COCHLEARIA OFF is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.
Availability is subject to change.

Cochlearia off label exampleCochlearia off label example

All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68428-919-032020-01-31C16284748780-19d75b9d0-af18-f424-e053-dadaa90a57ceDRUG FACTS
68428-919-052020-01-31C16284748780-19d75b9d0-af18-f424-e053-dadaa90a57ceDRUG FACTS
68428-919-062020-01-31C16284748780-19d75b9d0-af18-f424-e053-dadaa90a57ceDRUG FACTS
68428-919-112020-01-31C16284748780-19d75b9d0-af18-f424-e053-dadaa90a57ceDRUG FACTS
68428-919-122020-01-31C16284748780-19d75b9d0-af18-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68428-919-03Cochlearia officinalis75 in 1 VIAL, GLASSPELLET751
68428-919-05Cochlearia officinalis150 in 1 VIAL, GLASSPELLET1501
68428-919-06Cochlearia officinalis1200 in 1 BOTTLE, GLASSPELLET12001
68428-919-11Cochlearia officinalis300 in 1 BOTTLE, GLASSPELLET3001
68428-919-12Cochlearia officinalis600 in 1 BOTTLE, GLASSPELLET6001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68428-919COCHLEARIA OFFICINALIS (COCHLEARIA OFFICINALIS FLOWERING TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]1Legacy NDC, 5 package rows20170406_0be2f402-5e8e-4c72-90af-62d779cb3c77.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68428-91968428-919-03, 68428-919-05, 68428-919-11, 68428-919-12, 68428-919-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCHLEARIA OFFICINALIS FLOWERING TOPM87UN67CKRACTIB
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT

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
385b330f-b4d9-46bb-88e8-02debaebfa0e0be2f402-5e8e-4c72-90af-62d779cb3c772013-12-01WarningsExact identifier
spl id: 385b330f-b4d9-46bb-88e8-02debaebfa0e
spl set id: 0be2f402-5e8e-4c72-90af-62d779cb3c77

Reported adverse events (FAERS/openFDA)#

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