FDA.reportPublic FDA data

NativeRemedies® EndomtrEase™ Oral Spray

Manufacturer
Silver Star Brands | OHM Pharma
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:15

Label at a glance#

ProductEndometrEase
Active ingredientBLACK COHOSH, LILIUM LANCIFOLIUM WHOLE FLOWERING, ANEMONE PULSATILLA, IPECAC, SULFUR
Label structure10 sections

Indications and uses

Homeopathic remedy to promote healthy endometrial tissue. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Dosage and administration

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily until symptoms improve. Adults: 3 pump sprays.

Label contents#

Full prescribing information#

HPUS Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a 30C potency: Cimicifuga racemosa, Ipecacuanha, Lilium tigrinum, Pulsatilla, Sulphur.

Uses*:

INDICATIONS & USAGE SECTION

Homeopathic remedy to promote healthy endometrial tissue.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

WARNINGS SECTION

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily until symptoms improve. Adults: 3 pump sprays.

OTHER SAFETY INFORMATION

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com.

Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, potassium sorbate, purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Promotes healthy endometrial tissue

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EndometrEase LabelEndometrEase Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-302-022023-03-06C16284748780-19d75b9d0-6118-f424-e053-dadaa90a57ceNativeRemedies® EndomtrEase™ Oral Spray
68703-302-022020-01-31C16284748780-19d75b9d0-6118-f424-e053-dadaa90a57ceNativeRemedies® EndomtrEase™ Oral Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-302-02EndometrEase59 mL in 1 BOTTLE, SPRAYSPRAY593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-302ENDOMETREASE (CIMICIFUGA RACEMOSA, IPECACUANHA, LILIUM TIGRINUM, PULSATILLA, SULPHUR) SPRAY [SILVER STAR BRANDS]3Current NDC, Legacy NDC, 1 package rows20241204_579fffea-8c46-0a11-e053-2a91aa0a9135.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-30268703-302-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
BLACK COHOSHK73E24S6X9ACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
IPECAC62I3C8233LACTIB
SULFUR70FD1KFU70ACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT

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
EndometrEaseCIMICIFUGA RACEMOSA, IPECACUANHA, LILIUM TIGRINUM, PULSATILLA, SULPHURSilver Star Brands579fffea-8c46-0a11-e053-2a91aa0a91352024-12-02WarningsExact identifier
ndc (package): 68703-302-02
ndc (product): 68703-302
ndc11 (package): 68703030202
spl id: 2854c978-4453-e048-e063-6394a90a3516
spl set id: 579fffea-8c46-0a11-e053-2a91aa0a9135

Reported adverse events (FAERS/openFDA)#

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