Application 019435
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIX | PERMETHRIN | LOTION;TOPICAL | 1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019435-001 | NIX | PERMETHRIN | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019435-001 | NIX | 1% | LOTION / TOPICAL | 1986-03-31 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019435-001 | NIX | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | 1986-03-31 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Permethrin | PERMETHRIN | Dr. Reddy's Laboratories, Inc. | 31de941a-d5b9-8de5-6695-daca8b57d010 | 2026-07-24 | Warnings, Adverse reactions | PERMETHRIN |
| PERMETHRIN | PERMETHRIN | Aurobindo Pharma Limited | 0c92aca1-0daa-4b24-9348-f9d42fec478a | 2026-03-04 | Warnings, Adverse reactions | PERMETHRIN |
| Permethrin | PERMETHRIN | Bryant Ranch Prepack | 850414a5-a261-40ac-999e-cdcbd23c0cb0 | 2025-10-24 | Warnings, Adverse reactions | PERMETHRIN |
| Nix Complete Lice Treatment | PERMETHRIN | Insight Pharmaceuticals LLC | cca42777-01bf-4352-acdb-441160d69557 | 2025-10-23 | Warnings | PERMETHRIN |
| Nix | PERMETHRIN | Insight Pharmaceuticals LLC | d6dfa64a-bb88-4438-b4e2-30c6fbb28f3e | 2025-10-23 | Warnings | Nix PERMETHRIN |
| Permethrin | PERMETHRIN | Bryant Ranch Prepack | f4af5093-2e4a-43c6-b585-4bb14f73f370 | 2025-09-25 | Warnings, Adverse reactions | PERMETHRIN |
| Permethrin | PERMETHRIN | Northstar Rx LLC | 11e91140-cf12-42de-9f4a-cdbc22e74658 | 2025-05-16 | Warnings, Adverse reactions | PERMETHRIN |
| ELIMITE | PERMETHRIN | Aurobindo Pharma Limited | 443c0446-ccba-4f52-83ed-4c3163f35807 | 2024-01-24 | Warnings, Adverse reactions | PERMETHRIN |
| Permethrin | PERMETHRIN | Padagis Israel Pharmaceuticals Ltd | bdb796aa-a7d1-4476-988f-2b4a9519788f | 2023-01-31 | Warnings, Adverse reactions | PERMETHRIN |
| good sense lice killing creme rinse | PERMETHRIN | L. Perrigo Company | 056fb377-34dd-4d33-83d7-c895b105f574 | 2022-11-21 | Warnings | PERMETHRIN |
| Nix Lice Killing Creme Rinse | PERMETHRIN | Geodis Logistics LLC | cf7c2429-9ae0-4435-b695-aafd5f207d27 | 2022-02-07 | Warnings | PERMETHRIN |
| Topcare lice killing creme rinse | PERMETHRIN | Topco Associates LLC | 3b4146a6-7c54-4dd0-9388-1e38491d16f3 | 2020-01-31 | Warnings | PERMETHRIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57637 | ORIG | 2019-02-15 |