Home NDC 13811-092 Estradiol
Product NDC 13811-092
11-digit product format 138110092
Labeler code 13811
Product ID 13811-092_248c5ced-1972-443a-8cb0-de1e9ab011be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol
Dosage form GEL
Route TOPICAL
Labeler Trigen Laboratories, LLC
Application NDA022038
Marketing category NDA
Marketing start 2022-10-10
Substance ESTRADIOL
Active strength .75 mg/.75g
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022038-001 DIVIGEL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 N022038-002 DIVIGEL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 N022038-003 DIVIGEL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 N022038-004 DIVIGEL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 N022038-005 DIVIGEL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 94 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Estradiol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .75 mg/.75g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4TI98Z838E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2619677 Internal RxNorm lookup 2619679 Internal RxNorm lookup 2619681 Internal RxNorm lookup 2619683 Internal RxNorm lookup 2619685 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13811-092-32 Estradiol 30 in 1 CARTON GEL 30 8 13811-092-32 Estradiol 0.75 g in 1 PACKET GEL 0.75 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13811-092 ESTRADIOL GEL [TRIGEN LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240725_e84ad638-6768-41aa-b2b8-e2514ef63881.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13811-092-32 13811009232 30 PACKET in 1 CARTON (13811-092-32) / .75 g in 1 PACKET 30 packet 2022-10-10 0000-00-00 No No Current 13811-092-92 13811009292 90 PACKET in 1 CARTON (13811-092-92) / .75 g in 1 PACKET 90 packet 2026-08-20 0 Current