FDA.reportPublic FDA data

FemiClear Vulva Cream

Product NDC
71042-027
Requested package NDC
71042-027-14
11-digit product format
710420027
Labeler code
71042
Product ID
71042-027_419b44b2-6b9b-7daf-e063-6394a90a7c48
Type
HUMAN OTC DRUG
Nonproprietary name
FemiClear Vulva Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
OrganiCare Nature's Science, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-07-17
Substance
THYMOL; MELALEUCA CAJUPUTI LEAF OIL
Active strength
.0001; .0001 kg/100kg; kg/100kg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
FemiClear Vulva Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THYMOL.0001 kg/100kg
MELALEUCA CAJUPUTI LEAF OIL.0001 kg/100kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3J50XA376EInternal UNII lookup
5O59RMR6DUInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff1e9699-e5ec-621e-e053-6394a90a5479Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71042-027-14FemiClear Vulva Cream0.142 kg in 1 TUBECREAM0.1425
71042-027-14FemiClear Vulva Cream1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71042-027FEMICLEAR VULVA CREAM CREAM [ORGANICARE NATURE'S SCIENCE, LLC]4Current NDC, 2 package rows20241215_ff1e9699-e5ec-621e-e053-6394a90a5479.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
FemiClear Vulva CreamFEMICLEAR VULVA CREAMOrganiCare Nature's Science, LLCff1e9699-e5ec-621e-e053-6394a90a54792025-10-20WarningsExact identifier
ndc (package): 71042-027-14
ndc (product): 71042-027
ndc11 (package): 71042002714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71042-027-14710420027141 TUBE in 1 CARTON (71042-027-14) / .142 kg in 1 TUBE1 tube2023-07-17NoNoCurrent