Home NDC 13925-507 Fluocinolone Acetonide
Product NDC 13925-507
11-digit product format 139250507
Labeler code 13925
Product ID 13925-507_1dadd23b-4d35-4fda-a153-edb72ad90111
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form OIL
Route TOPICAL
Labeler Seton Pharmaceuticals
Application NDA019452
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-08-01
Marketing end 0000-00-00
Substance FLUOCINOLONE ACETONIDE
Active strength 0 mg/mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13925-507-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 13925-507-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 13925-507-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 13925-507-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 13925-507-04 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 13925-507-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 13925-507-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 13925-507-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019452-001 DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 N019452-002 DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 N019452-003 DERMOTIC FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 132 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 2026-10-15 13:18:30 2026-09 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019452-002 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019452-003 DERMOTIC 0.01% OIL/DROPS / OTIC AT RLD, RS 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019452-001 DERMA-SMOOTHE/FS 0.01% OIL / TOPICAL AT RLD, RS 1988-02-03 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DERMOTIC FLUOCINOLONE ACETONIDE Royal Pharmaceuticals eb00f222-8105-4e05-90e8-bbd129784364 2025-05-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 019452 application number: NDA019452