Fluocinolone acetonide 0.01%
- Product NDC
- 13925-508
- 11-digit product format
- 139250508
- Labeler code
- 13925
- Product ID
- 13925-508_dfb898fc-1e28-4c46-ab2e-16139107ac4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- OIL
- Route
- AURICULAR (OTIC)
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 13925-508 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 13925-508 | 13925-508-20 | D | Discontinued by firm | 2026-08-07 |
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.
| 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 | 13925-508-20 | 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 | 13925-508-20 | 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 | 13925-508-20 | 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 | 13925-508-20 | 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 | 13925-508-20 | 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 | 13925-508-20 | 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 | 13925-508-20 | 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 | 13925-508-20 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N019452-001 | AT |
| N019452-002 | AT |
| N019452-003 | AT |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019452-002 | DERMA-SMOOTHE/FS | 0.01% | OIL / TOPICAL | AT | RLD, RS | 2005-11-09 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019452-003 | DERMOTIC | 0.01% | OIL/DROPS / OTIC | AT | RLD, RS | 2005-11-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019452-001 | DERMA-SMOOTHE/FS | 0.01% | OIL / TOPICAL | AT | RLD, RS | 1988-02-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019452-002 | DERMA-SMOOTHE/FS | 0.01% | OIL / TOPICAL | AT | RLD, RS | 2005-11-09 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019452-003 | DERMOTIC | 0.01% | OIL/DROPS / OTIC | AT | RLD, RS | 2005-11-09 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019452-001 | DERMA-SMOOTHE/FS | 0.01% | OIL / TOPICAL | AT | RLD, RS | 1988-02-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019452-002 | DERMA-SMOOTHE/FS | 0.01% | OIL / TOPICAL | AT | RLD, RS | 2005-11-09 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019452-003 | DERMOTIC | 0.01% | OIL/DROPS / OTIC | AT | RLD, RS | 2005-11-09 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019452-001 | DERMA-SMOOTHE/FS | 0.01% | OIL / TOPICAL | AT | RLD, RS | 1988-02-03 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019452-001 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019452-002 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019452-003 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019452-001 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019452-002 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019452-003 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019452-001 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019452-002 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019452-003 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019452-001 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019452-002 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019452-003 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019452-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019452-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019452-003 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019452-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019452-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019452-003 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019452-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019452-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019452-003 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019452-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019452-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019452-003 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019452-001 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019452-002 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019452-003 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019452-001 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019452-002 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019452-003 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019452-001 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019452-002 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019452-003 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019452-001 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019452-002 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019452-003 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019452-001 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019452-002 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019452-003 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019452-001 | AT | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13925-508-20 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-259f-f424-e053-dadaa90a57ce | Fluocinolone Acetonide 0.01% Oil Ear Drops |
| 13925-508-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-259f-f424-e053-dadaa90a57ce | Fluocinolone Acetonide 0.01% Oil Ear Drops |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13925-508-20 | ML - Milliliter | 13925-508 | f284e36f-bf1f-4e3f-a628-c219596ffdc5 | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| fluocinolone acetonide | ACTIVE INGREDIENT | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 | |
| fluocinolone acetonide | ACTIVE MOIETY | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 | |
| OLETH-2 | INACTIVE INGREDIENT | 7L6R1SQ6M0 | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 | |
| PEANUT OIL | INACTIVE INGREDIENT | 5TL50QU0W4 | FLUOCINOLONE ACETONIDE 0.01% (FLUOCINOLONE ACETONIDE) OIL [SETON PHARMACEUTICALS] | 2 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Derma-Smoothe/FS | FLUOCINOLONE ACETONIDE | Royal Pharmaceuticals, LLC | bc61c619-a71c-46f5-80f1-9e9ee71134aa | 2026-06-09 | Warnings, Adverse reactions | 019452 NDA019452 |
| DERMA-SMOOTHE/FS | FLUOCINOLONE ACETONIDE | Royal Pharmaceuticals | 113e167a-a9fe-440e-9446-d6d87963ef46 | 2026-06-09 | Warnings, Adverse reactions | 019452 NDA019452 |
| DERMOTIC | FLUOCINOLONE ACETONIDE | Royal Pharmaceuticals | eb00f222-8105-4e05-90e8-bbd129784364 | 2025-05-09 | Warnings, Adverse reactions | 019452 NDA019452 |