Active ingredient
Fluocinolone
49 finished FDA listings contain Fluocinolone as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUOCINOLONE ACETONIDE
- Dosage forms
- Cream, Implant, Oil, Ointment, Solution
- Routes
- Auricular (Otic), Intravitreal, Topical
- Manufacturers / labelers
- 21
- Strengths listed
- .01 mg/100ml · .1 mg/g · .1 mg/ml · .11 mg/118.28ml · .11 mg/ml · .18 mg/1 · .19 mg/1 · .25 mg/g · .59 mg/1
- Brand names in FDA listings
- Derma-Smoothe/Fs, Dermotic, Flac Otic Oil, Fluocinolone Acetonide Oil, Iluvien, Retisert, Synalar, Yutiq
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 25126
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 012787 | EUROFARMA | 1963-02-15 | 3 |
| NDA 013960 | EUROFARMA | 1963-06-19 | 2 |
| ANDA 088167 | FOUGERA PHARMS INC | 1982-12-16 | 1 |
| ANDA 088168 | FOUGERA PHARMS INC | 1982-12-16 | 1 |
| ANDA 089124 | SUN PHARMA CANADA | 1985-09-11 | 1 |
| NDA 019452 | HILL DERMAC | 1988-02-03 | 3 |
| ANDA 089524 | COSETTE PHARMS NC | 1988-07-26 | 1 |
| ANDA 089526 | COSETTE PHARMS NC | 1988-07-26 | 1 |
| NDA 021737 | BAUSCH AND LOMB | 2005-04-08 | 1 |
| ANDA 201759 | AMNEAL | 2011-10-17 | 1 |
| ANDA 202848 | PADAGIS ISRAEL | 2013-08-09 | 4 |
| ANDA 202847 | PADAGIS ISRAEL | 2013-08-09 | 3 |
| NDA 201923 | ALIMERA SCIENCES INC | 2014-09-26 | 1 |
| ANDA 206422 | LUPIN | 2015-09-02 | 1 |
| ANDA 090982 | RISING | 2016-04-25 | 2 |
| ANDA 203377 | RISING | 2016-04-25 | 1 |
| ANDA 203378 | RISING | 2016-04-25 | 1 |
| ANDA 202368 | SUN PHARMA CANADA | 2016-05-19 | 1 |
| ANDA 209336 | SUN PHARMA CANADA | 2016-05-19 | 1 |
| ANDA 208386 | ACTAVIS LABS UT INC | 2016-10-21 | 1 |
| ANDA 202849 | PADAGIS ISRAEL | 2017-07-17 | 1 |
| ANDA 210736 | ANDA REPOSITORY | 2018-04-11 | 1 |
| NDA 210331 | ALIMERA SCIENCES INC | 2018-10-12 | 1 |
| ANDA 210539 | GLENMARK PHARMS LTD | 2018-10-26 | 1 |
| ANDA 210747 | COSETTE PHARMS NC | 2018-11-05 | 1 |
| ANDA 211815 | GLENMARK PHARMS LTD | 2018-12-14 | 1 |
| ANDA 209913 | ENCUBE ETHICALS | 2019-02-13 | 3 |
| ANDA 212762 | QUAGEN | 2021-04-02 | 3 |
| ANDA 212761 | QUAGEN | 2021-04-02 | 3 |
| ANDA 212760 | QUAGEN | 2021-04-02 | 3 |
Official labeling on DailyMed
- FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK] · version 102 · 2026-06-22
- DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS, LLC] · version 15 · 2026-06-12
- DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS] · version 16 · 2026-06-12
- FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK] · version 104 · 2026-05-28
- FLUOCINOLONE ACETONIDE OIL [A-S MEDICATION SOLUTIONS] · version 1 · 2026-05-11
- RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED] · version 16 · 2026-04-02
- FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% SOLUTION [ENCUBE ETHICALS, INC.] · version 6 · 2026-03-19
- FLUOCINOLONE ACETONIDE OIL (FLUOCINOLONE ACETONIDE) OIL [RISING PHARMA HOLDINGS, INC.] · version 6 · 2026-03-11
- FLUOCINOLONE ACETONIDE OIL (FLUOCINOLONE ACETONIDE) OIL [RISING PHARMA HOLDINGS, INC.] · version 9 · 2026-03-11
- FLUOCINOLONE ACETONIDE OINTMENT [ANI PHARMACEUTICALS, INC.] · version 2 · 2026-03-03
- FLUOCINOLONE ACETONIDE CREAM [ANI PHARMACEUTICALS, INC.] · version 3 · 2026-03-03
- YUTIQ (FLUOCINOLONE ACETONIDE) IMPLANT [ANI PHARMACEUTICALS, INC.] · version 4 · 2026-02-23
Showing the 12 most recent of 46 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.