LEMOTO BIOIDENTICAL ESTROGEN VAGINAL Cream

Product NDC: 87786-010
Requested package NDC: 87786-010-01
11-digit product format: 877860010
Labeler code: 87786
Product ID: 87786-010_55acee3d-8204-3c7f-e063-6394a90a1e48
Type: HUMAN OTC DRUG
Nonproprietary name: Micronized Estriol 0.1% BIOIDENTICAL ESTROGEN VAGINAL Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Wenzhou Yuyuan Pharmaceutical Co., Ltd.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-07-03
Substance: ESTRIOL
Active strength: .1 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: LEMOTO BIOIDENTICAL ESTROGEN VAGINAL Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRIOL	.1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FB33469R8E	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
55acee3d-8203-3c7f-e063-6394a90a1e48	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEMOTO BIOIDENTICAL ESTROGEN VAGINAL Cream	MICRONIZED ESTRIOL 0.1% BIOIDENTICAL ESTROGEN VAGINAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	55acee3d-8203-3c7f-e063-6394a90a1e48	2026-07-02	Warnings	Exact identifier ndc (package): 87786-010-01 ndc (product): 87786-010 ndc11 (package): 87786001001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FB33469R8E	ESTRIOL	50-27-1	ESTRIOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87786-010-01	87786001001	50 mL in 1 BOTTLE (87786-010-01)	50 ml	2026-07-03	No	No	Current