Estriora Cream

Product NDC: 87976-001
Requested package NDC: 87976-001-01
11-digit product format: 879760001
Labeler code: 87976
Product ID: 87976-001_5a53c026-aa7d-6c09-e063-6394a90a36e1
Type: HUMAN OTC DRUG
Nonproprietary name: Estriol and Estradiol Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Guangzhou Shunfei Network Technology Co., Ltd.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-08-31
Substance: ESTRIOL; ESTRADIOL
Active strength: .2; .01 g/100g; g/100g
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
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: Estriora Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRIOL	.2 g/100g
ESTRADIOL	.01 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FB33469R8E	Internal UNII lookup
4TI98Z838E	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
5a53c026-aa7c-6c09-e063-6394a90a36e1	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
Estriora Cream	ESTRIOL AND ESTRADIOL CREAM	Guangzhou Shunfei Network Technology Co., Ltd.	5a53c026-aa7c-6c09-e063-6394a90a36e1	2026-08-31	Warnings	Exact identifier ndc (package): 87976-001-01 ndc (product): 87976-001 ndc11 (package): 87976000101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FB33469R8E	ESTRIOL	50-27-1	ESTRIOL
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87976-001-01	87976000101	30 g in 1 TUBE (87976-001-01)	30 g	2026-08-31	No	No	Current