Application 008048
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYLOCAINE | LIDOCAINE | OINTMENT;TOPICAL | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N008048-001 | XYLOCAINE | LIDOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 |
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| 2026-08 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008048-001 | XYLOCAINE | 5% | OINTMENT / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008048-001 | XYLOCAINE | 5% | OINTMENT / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N008048-001 | XYLOCAINE | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / TOPICAL | RLD, Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| VBBV Anorectal(Hemorrhoidal) Creams | LIDOCAINE | Jiashen International Trading Co., Ltd. | 3cba84ea-5ee0-7ee3-e063-6294a90af11b | 2025-08-19 | Warnings | LIDOCAINE |
| Orythia Maximum Strength Lidocaine Pain Relieving | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 | 2025-08-18 | Warnings | LIDOCAINE |
| Ocean Potion Suncare Ice Plus Pain Relieving Soothing | LIDOCAINE | GNL BRANDS INTERNATIONAL, LLC | 3c69654c-cba6-dfef-e063-6394a90ad479 | 2025-08-15 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | A-S Medication Solutions | e23a92e6-3445-4ba7-9ad2-86a3eec1717e | 2025-08-15 | Warnings, Adverse reactions | LIDOCAINE |
| Burn | LIDOCAINE | HART Health | c5ff392a-e788-43e0-91ea-5e0f8420586c | 2025-08-15 | Warnings | LIDOCAINE |
| Signature Care Aloe Vera Gel with Lidocaine | LIDOCAINE | Safeway, Inc. | d5069622-97b1-ba12-e053-2a95a90a7268 | 2025-08-14 | Warnings | LIDOCAINE |
| Careland X-large Lidocaine 4 Pain Relieving | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | a6867506-4a46-47b1-b5b6-bfedb59dfde6 | 2025-08-11 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Gel Roll-On | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 31639407-0f11-bde2-e063-6294a90af694 | 2025-08-10 | Warnings | LIDOCAINE |
| Chinese Red Tiger Lidocaine Patches | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 20cd369c-3e98-3d8f-e063-6394a90a0824 | 2025-08-10 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Bryant Ranch Prepack | 015cea25-d323-43dd-a92f-593a8e4a2921 | 2025-08-07 | Warnings, Adverse reactions | LIDOCAINE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION | Henry Schein, Inc | 9e8d0318-b2fe-4084-aedf-de97f61605a8 | 2025-08-07 | Warnings, Adverse reactions | Xylocaine |
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | LIDOCAINE |
| AIPATCH NUMBING PAIN RELIEF | LIDOCAINE | Active Intelligence, LLC | 56f27540-9b2a-4266-9e15-a5b2d738c7a1 | 2025-07-25 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Advanced Rx of Tennessee, LLC | 3a9a6630-e470-b794-e063-6394a90aaab5 | 2025-07-23 | Warnings, Adverse reactions | LIDOCAINE |
| Arthcal 4% Lidocaine Patches | LIDOCAINE | Beijing JUNGE Technology Co., Ltd. | 2e531194-67ad-c645-e063-6394a90a916c | 2025-07-22 | Warnings | LIDOCAINE |
| LIDOCAINE | LIDOCAINE | PHOENIX RX LLC | 3a63652c-92a1-612b-e063-6294a90a034a | 2025-07-21 | Warnings, Adverse reactions | LIDOCAINE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | ProPharma Distribution | 386c23fd-1691-98b2-e063-6294a90ab070 | 2025-07-18 | Warnings, Adverse reactions | Xylocaine |
| OTC Rescue Lidocaine Pain Relief Patch | LIDOCAINE | Veridian Healthcare | 0e742fc6-5f76-d202-e063-6394a90acf31 | 2025-07-16 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Golden State Medical Supply, Inc. | b948d6fe-3893-39a1-e053-2995a90ae64c | 2025-07-11 | Warnings, Adverse reactions | LIDOCAINE |
| INVIGOR OH | LIDOCAINE | Natureplex LLC | 7c7b536d-e41a-4017-9df9-982e2e9cfe4e | 2025-07-10 | Warnings | LIDOCAINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.