BiEST 5.0 Estrogen Cream

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: BiEST 5.0 Estrogen Cream
Generic name: ESTRIOL,ESTRADIOL
Manufacturer: SHYNE BRANDS
Product type: HUMAN OTC DRUG
SPL set ID: c4d3860f-c211-b18c-e053-2a95a90a4474
SPL ID: 37ca001c-de9a-f819-e063-6294a90a4c08
Version: 4
Effective date: 2025-06-01
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:56:18

Harmonized routes table
Harmonized routes
TRANSDERMAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		BiEST 5.0 Estrogen Cream	openfda.brand_name
generic name		ESTRIOL,ESTRADIOL	openfda.generic_name
manufacturer name		SHYNE BRANDS	openfda.manufacturer_name
ndc	package	82018-0009-3	openfda.package_ndc
ndc	product	82018-0009	openfda.product_ndc
ndc11	package	82018000903	derived:openfda.package_ndc
spl id		37ca001c-de9a-f819-e063-6294a90a4c08	id
spl set id		c4d3860f-c211-b18c-e053-2a95a90a4474	set_id
unii		4TI98Z838E	openfda.unii
unii		FB33469R8E	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

For external cosmetic use only. If pregnant or nursing, consult a healthcare professional before using this product. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement: This product contains estrogen, a chemical known only to the state of California to cause cancer. KEEP OUT OF REACH OF CHILDREN.

Reported adverse events (FAERS/openFDA)#

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