FDA.reportPublic FDA data

JOVYNEX WOMEN ESTRIOL

Product NDC
85248-154
11-digit product format
852480154
Labeler code
85248
Product ID
85248-154_4c6582d6-577f-9bf1-e063-6394a90a4034
Type
HUMAN OTC DRUG
Nonproprietary name
Micronized Estriol 0.1 WOMEN ESTRIOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-07
Substance
ESTRIOL
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JOVYNEX WOMEN ESTRIOL
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FB33469R8EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c6582d6-577e-9bf1-e063-6394a90a4034Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-154-01JOVYNEX WOMEN ESTRIOL30 g in 1 BOTTLECREAM301
85248-154-02JOVYNEX WOMEN ESTRIOL50 g in 1 BOTTLECREAM501
85248-154-03JOVYNEX WOMEN ESTRIOL100 g in 1 BOTTLECREAM1001

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
JOVYNEX WOMEN ESTRIOLMICRONIZED ESTRIOL 0.1 WOMEN ESTRIOLJiangxi Yudexi Pharmaceutical Co., LTD4c6582d6-577e-9bf1-e063-6394a90a40342026-07-20WarningsExact identifier
ndc (product): 85248-154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-154-018524801540130 g in 1 BOTTLE (85248-154-01) 30 g2026-03-07NoNoCurrent
85248-154-028524801540250 g in 1 BOTTLE (85248-154-02) 50 g2026-03-07NoNoCurrent
85248-154-0385248015403100 g in 1 BOTTLE (85248-154-03) 100 g2026-03-07NoNoCurrent