Home NDC 82018-0009-3 BiEST 5.0 Estrogen Cream
Product NDC 82018-0009
Requested package NDC 82018-0009-3
11-digit product format 820180009
Labeler code 82018
Product ID 82018-0009_37ca001c-de9a-f819-e063-6294a90a4c08
Type HUMAN OTC DRUG
Nonproprietary name estriol,estradiol
Dosage form CREAM
Route TRANSDERMAL
Labeler SHYNE BRANDS
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-06-01
Substance ESTRADIOL; ESTRIOL
Active strength 1; 4 mg/85g; mg/85g
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base BiEST 5.0 Estrogen Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRIOL 1 mg/85g ESTRADIOL 4 mg/85g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FB33469R8E Internal UNII lookup 4TI98Z838E Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82018-0009-3 BiEST 5.0 Estrogen Cream 85 g in 1 BOTTLE, PUMP CREAM 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82018-0009 BIEST 5.0 ESTROGEN CREAM (ESTRIOL,ESTRADIOL) CREAM [SHYNE BRANDS] 3 Current NDC, Legacy NDC, 1 package rows 20210622_c4d3860f-c211-b18c-e053-2a95a90a4474.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82018-0009-3 82018000903 85 g in 1 BOTTLE, PUMP (82018-0009-3) 85 g 2025-06-01 0000-00-00 No No Current