FDA.reportPublic FDA data

Coffea cruda

Manufacturer
Washington Homeopathic Products
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:22:44

Label at a glance#

ProductCoffea cruda
Active ingredientARABICA COFFEE BEAN
Label structure8 sections

Indications and uses

To relieve the symptoms of sleeplessness.

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

COFFEA CRUDA

USES

OTC - PURPOSE SECTION

To relieve the symptoms of sleeplessness.

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:

COFFEA CRUDA   Sleeplessness

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 COFFEA CRUDA is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.

Availability is subject to change.

Coffea2023Coffea2023

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
68428-331-032025-01-30C16284748780-12cef2736-9c9a-d83d-e063-dadaa90ab31fDRUG FACTS
68428-331-052025-01-30C16284748780-12cef2736-9c9a-d83d-e063-dadaa90ab31fDRUG FACTS
68428-331-062025-01-30C16284748780-12cef2736-9c9a-d83d-e063-dadaa90ab31fDRUG FACTS
68428-331-112025-01-30C16284748780-12cef2736-9c9a-d83d-e063-dadaa90ab31fDRUG FACTS
68428-331-122025-01-30C16284748780-12cef2736-9c9a-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68428-331-03Coffea cruda75 in 1 VIAL, GLASSPELLET753
68428-331-05Coffea cruda150 in 1 VIAL, GLASSPELLET1503
68428-331-06Coffea cruda1200 in 1 BOTTLE, GLASSPELLET12003
68428-331-11Coffea cruda300 in 1 BOTTLE, GLASSPELLET3003
68428-331-12Coffea cruda600 in 1 BOTTLE, GLASSPELLET6003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68428-331COFFEA CRUDA (ARABICA COFFEE BEAN) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3Legacy NDC, 5 package rows20231019_b37d601e-bb51-47be-86ee-373026d76fe8.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
68428-33168428-331-03, 68428-331-05, 68428-331-11, 68428-331-12, 68428-331-06

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
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT
ARABICA COFFEE BEAN3SW678MX72ACTIB

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
0803f6f1-9d70-230d-e063-6294a90a6831b37d601e-bb51-47be-86ee-373026d76fe82023-10-18WarningsExact identifier
spl id: 0803f6f1-9d70-230d-e063-6294a90a6831
spl set id: b37d601e-bb51-47be-86ee-373026d76fe8

Reported adverse events (FAERS/openFDA)#

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