Estriol 5.0 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: Estriol 5.0 Cream
Generic name: ESTRIOL
Manufacturer: SHYNE BRANDS
Product type: HUMAN OTC DRUG
SPL set ID: c4d3d276-f78e-17c1-e053-2995a90a590d
SPL ID: 37c9f33a-9823-ec65-e063-6294a90a6773
Version: 4
Effective date: 2025-06-01
Source export date: 2026-11-06
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:24:45

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 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Estriol 5.0 Cream	openfda.brand_name
generic name		ESTRIOL	openfda.generic_name
manufacturer name		SHYNE BRANDS	openfda.manufacturer_name
ndc	package	82018-0010-4	openfda.package_ndc
ndc	product	82018-0010	openfda.product_ndc
ndc11	package	82018001004	derived:openfda.package_ndc
spl id		37c9f33a-9823-ec65-e063-6294a90a6773	id
spl set id		c4d3d276-f78e-17c1-e053-2995a90a590d	set_id
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.