EndometrEase

Product NDC
68703-302
11-digit product format
687030302
Labeler code
68703
Product ID
68703-302_2854c978-4453-e048-e063-6394a90a3516
Type
HUMAN OTC DRUG
Nonproprietary name
Cimicifuga racemosa, Ipecacuanha, Lilium tigrinum, Pulsatilla, Sulphur
Dosage form
SPRAY
Route
ORAL
Labeler
Silver Star Brands
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-06-05
Substance
ANEMONE PULSATILLA; BLACK COHOSH; IPECAC; LILIUM LANCIFOLIUM WHOLE FLOWERING; SULFUR
Active strength
30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68703-302-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68703-302-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68703-302-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68703-302-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68703-302-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68703-302-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68703-302-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
EndometrEase
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH30 [hp_C]/59mL
LILIUM LANCIFOLIUM WHOLE FLOWERING30 [hp_C]/59mL
ANEMONE PULSATILLA30 [hp_C]/59mL
IPECAC30 [hp_C]/59mL
SULFUR30 [hp_C]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K73E24S6X9Internal UNII lookup
X67Z2963PIInternal UNII lookup
I76KB35JEVInternal UNII lookup
62I3C8233LInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
579fffea-8c46-0a11-e053-2a91aa0a9135Available on FDA.report

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

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 (product): 68703-302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68703-302-026870303020259 mL in 1 BOTTLE, SPRAY (68703-302-02) 59 ml2017-06-05NoNoCurrent