Synalar
- Product NDC
- 43538-900
- 11-digit product format
- 435380900
- Labeler code
- 43538
- Product ID
- 43538-900_890554e0-30dd-4f2c-a469-f8822ca89cab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medimetriks Pharmaceuticals, Inc.
- Application
- NDA012787
- Marketing category
- NDA
- Marketing start
- 2012-09-27
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .25 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012787-002 | SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | |
| N012787-004 | SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | |
| N012787-005 | SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N012787-002 | AT |
| N012787-004 | AT |
| N012787-005 | 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 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012787-004 | SYNALAR | 0.01% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012787-005 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N012787-002 | SYNALAR | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 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 | N012787-002 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N012787-004 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N012787-005 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012787-002 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012787-004 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012787-005 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N012787-002 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N012787-004 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N012787-005 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012787-002 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012787-004 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012787-005 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012787-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012787-004 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012787-005 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012787-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012787-004 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012787-005 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012787-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012787-004 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012787-005 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012787-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012787-004 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012787-005 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012787-002 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012787-004 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012787-005 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N012787-002 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N012787-004 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N012787-005 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012787-002 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012787-004 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012787-005 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012787-002 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012787-004 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012787-005 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012787-002 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012787-004 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012787-005 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N012787-002 | AT | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Synalar
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUOCINOLONE ACETONIDE | .25 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0CD5FD6S2M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0adb2af5-1ecf-4df5-912b-16ae89228294 | Product name | 6 | 20240829 |
| 65f6255d-41cc-425f-ba54-b1bea4947886 | Product name | 5 | 20210930 |
| 5ba208e4-886f-44da-e218-ab4f4cad2c49 | Product name | 5 | 20190612 |
| e5a2793f-318b-72fd-b734-c44ecc6f6748 | Product name | 2 | 20190213 |
| 9e453f34-aacb-44d5-a119-c0e3dc1fca2a | Product name | 1 | 20160622 |
| 7df2570a-c555-4d82-9189-9247c722b62c | Product name | 1 | 20150402 |
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
| a78a3633-fd06-b0af-63b3-c714de3b3bfa | Product name | 1 | 20140508 |
| b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 43538-900-12 | 2023-12-08 | SYNALAR ® (fluocinolone acetonide) Cream, 0.025% |
| 43538-900-99 | 2023-12-08 | SYNALAR ® (fluocinolone acetonide) Cream, 0.025% |
| 43538-900-12 | 2023-07-28 | SYNALAR ® (fluocinolone acetonide) Cream, 0.025% |
| 43538-900-99 | 2023-07-28 | SYNALAR ® (fluocinolone acetonide) Cream, 0.025% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43538-900-12 | Synalar | 120 g in 1 TUBE | CREAM | 120 | 8 | |
| 43538-900-12 | Synalar | 1 in 1 CARTON | CREAM | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43538-900-12 | GM - Gram | 43538-900 | 51933d34-4801-441f-aba6-1fcd680370fc | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| fluocinolone acetonide | FLUOCINOLONE ACETONIDE | ANI Pharmaceuticals, Inc. | 50e7006d-a51b-49aa-8e1c-330340e7bf82 | 2026-02-23 | Adverse reactions | 012787 NDA012787 |
| Synalar | FLUOCINOLONE ACETONIDE | Medimetriks Pharmaceuticals, Inc. | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 2024-07-18 | Adverse reactions | 012787 NDA012787 43538-900 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191315 | fluocinolone acetonide 0.025 % Topical Cream | PSN | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
| 1191319 | SYNALAR 0.025 % Topical Cream | PSN | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
| 1191319 | fluocinolone acetonide 0.25 MG/ML Topical Cream [Synalar] | SBD | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
| 1191315 | fluocinolone acetonide 0.25 MG/ML Topical Cream | SCD | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
| 1191315 | fluocinolone acetonide 0.025 % Topical Cream | SY | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
| 1191319 | Synalar 0.025 % Topical Cream | SY | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
| 1191319 | Synalar 0.25 MG/ML Topical Cream | SY | 5af2e4c1-082b-48a0-aae7-72d4a68cbb2d | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43538-900-12 | 43538090012 | 1 TUBE in 1 CARTON (43538-900-12) / 120 g in 1 TUBE | 1 tube | 2012-09-27 | 0000-00-00 | No | No | Current |
| 43538-900-99 | 43538090099 | 6 TUBE in 1 CARTON (43538-900-99) > 3 g in 1 TUBE | 6 tube | 2012-09-27 | 0000-00-00 | No | No | Current |