Over-the-counter medicine
Estriol
Estriol is an over-the-counter medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Over the counter
Check it at the source: the estriol FDA label on DailyMed (effective August 27, 2026); every estriol label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHelps maintain hormonal balance.
Forms and strengths
- 0.2 g/100ml
Cream.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included; 9 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest December 9, 2019; 25 more by firms not listed as its makers
- FAERS reports
- 2,912 through July 30, 2026
What is estriol used for?
From the label: indications and usageHelps maintain hormonal balance. May help ease symptoms associated with menopause.
Source: FDA drug label (Estriol Cream), Guangxi Keyun E-commerce Co., Ltd., effective August 27, 2026 (SPL set 4deadcb6-0d46-bdd7-e063-6294a90a26d7), via openFDA; the full label on DailyMed
Is there a generic for estriol?
No generic estriol is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists estriol from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has estriol been recalled?
The FDA's Enforcement Report lists 29 recalls naming estriol since 2013: 0 Class I (the most serious), 29 Class II, 0 Class III; 0 still ongoing. 25 of them are by firms that FDA's NDC Directory does not list as a maker of estriol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 10, 2022 | Class II | Wedgewood Village Pharmacy, LLC not a listed maker | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection |
| July 2, 2020 | Class II | MasterPharm LLC not a listed maker | Lack of Processing Controls (lack of assurance of conformity to specifications). |
| April 6, 2020 | Class II | The Medicine Shoppe Pharmacy not a listed maker | Lack of Processing Control |
| December 11, 2019 | Class II | Spectrum Laboratory Products not a listed maker | Subpotent Drug: Supplier indicated assay results did not meet specifications. |
| December 9, 2019 | Class II | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. |
| November 25, 2019 | Class II | Medisca, Inc. not a listed maker | Failed Impurities/Degradation Specifications |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| October 25, 2017 | Class II | Fagron, Inc not a listed maker | cGMP Deviations: lack of quality assurance at the API manufacturer. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the estriol label say about other medicines?
The estriol label names no other medicine on this site. The labels of 3 other medicines name estriol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name estriol
Source: FDA drug label (Estriol Cream), Guangxi Keyun E-commerce Co., Ltd., effective August 27, 2026 (SPL set 4deadcb6-0d46-bdd7-e063-6294a90a26d7), via openFDA; the full label on DailyMed
What do FAERS reports show for estriol?
The FDA Adverse Event Reporting System holds 2,912 reports that list estriol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 80 are coded as a death and 506 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Estriol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other