Estriol 5.0 Cream

Product NDC
82018-0010
11-digit product format
820180010
Labeler code
82018
Product ID
82018-0010_37c9f33a-9823-ec65-e063-6294a90a6773
Type
HUMAN OTC DRUG
Nonproprietary name
estriol
Dosage form
CREAM
Route
TRANSDERMAL
Labeler
SHYNE BRANDS
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-06-01
Substance
ESTRIOL
Active strength
5 mg/85g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Estriol 5.0 Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRIOL5 mg/85g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFB33469R8E

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82018-0010-42025-06-17C16284748780-1f386c64a-3a13-0266-e053-dadaa90a7c1aEstriol 5.0 Cream
82018-0010-42023-01-30C16284748780-1f386c64a-3a13-0266-e053-dadaa90a7c1aEstriol 5.0 Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0010-4Estriol 5.0 Cream85 g in 1 BOTTLE, PUMPCREAM854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82018-0010ESTRIOL 5.0 CREAM (ESTRIOL) CREAM [SHYNE BRANDS]3Current NDC, Legacy NDC, 1 package rows20210622_c4d3d276-f78e-17c1-e053-2995a90a590d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82018-0010-48201800100485 g in 1 BOTTLE, PUMP (82018-0010-4) 85 g2025-06-010000-00-00NoNoCurrent