Application 014394
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYLOCAINE | LIDOCAINE | AEROSOL;ORAL | 10% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N014394-001 | XYLOCAINE | LIDOCAINE | 10% | AEROSOL / ORAL | 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 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N014394-001 | XYLOCAINE | 10% | AEROSOL / ORAL | 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 |
|---|---|---|---|---|---|---|
| Lidocaine | LIDOCAINE | ASCLEMED USA INC. | 56a54ef4-7aa0-e181-e063-6394a90a3e0e | 2026-07-15 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine Numbing Cream | LIDOCAINE | KORVIA GLOBAL Inc. | 5690db03-4d62-9660-e063-6394a90a2fc0 | 2026-07-14 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Gel -Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 51d32d7c-3ba7-81cd-e063-6294a90a2041 | 2026-07-14 | Warnings | LIDOCAINE |
| Zmztuhua Numbing Cream | LIDOCAINE | Guangzhou Hechuang Commercial Service Co.,Ltd. | 56417dc6-c14b-ad17-e063-6294a90af7e5 | 2026-07-10 | Warnings | LIDOCAINE |
| Burn Relief | LIDOCAINE | AmerisourceBergen Drug Corporation | 7d898e33-ded7-c9b9-e053-2a91aa0adf7c | 2026-07-01 | Warnings | LIDOCAINE |
| Desert Harvest RELEVEUM | LIDOCAINE | Desert Harvest Inc. | 5d9010ec-d482-44ff-ba27-3bfec5a241c6 | 2026-06-30 | Warnings | LIDOCAINE |
| Pain Relieving Gel-Patch | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 556028b3-06f7-0720-e063-6294a90a2df8 | 2026-06-29 | Warnings | LIDOCAINE |
| NUMBING | LIDOCAINE | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 5553385d-c1e6-1242-e063-6394a90aa5a7 | 2026-06-28 | Warnings | LIDOCAINE |
| Adellina Lidocaine Numbing Cream Topical Anorectal Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 55260a3e-637a-c53b-e063-6394a90a1b09 | 2026-06-27 | Warnings | LIDOCAINE |
| MOROVAN | LIDOCAINE | HONG KONG UNORDERED TRADING CO., LIMITED | 550c8d2d-e0d7-1531-e063-6394a90a374d | 2026-06-25 | Warnings | LIDOCAINE |
| Careland Kinesiology Dual Action Pain Relieving Tape | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 67e0b3c5-e88e-4c48-a1e8-39f502ac249d | 2026-06-18 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Golden State Medical Supply, Inc. | 0bef12dd-6cea-d12b-e063-6394a90a002e | 2026-06-18 | Warnings, Adverse reactions | LIDOCAINE |
| Zensa | LIDOCAINE | Alera Skin Care Products Inc. | 549348ec-2eb2-3781-e063-6294a90a2f4a | 2026-06-18 | Warnings | LIDOCAINE |
| Tridacaine II | LIDOCAINE | Trifluent Pharma LLC | 1e940ba6-3916-4fc4-8886-481fc9685fc1 | 2026-06-12 | Warnings, Adverse reactions | LIDOCAINE |
| lidocaine | LIDOCAINE | REMEDYREPACK INC. | 2cc3d25d-cefd-448d-beec-ac602c2110fd | 2026-06-11 | Warnings, Adverse reactions | LIDOCAINE |
| lidocaine | LIDOCAINE | REMEDYREPACK INC. | 499b4443-7aed-4ac5-ab16-f47e759c3201 | 2026-06-10 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine 4 Percent | LIDOCAINE | Preferred Pharmaceuticals Inc. | ce379d77-bba4-4f8c-a42c-27ce06aa38a5 | 2026-06-09 | Warnings | LIDOCAINE |
| Quality Choice Lidocaine Pain Relief Patch | LIDOCAINE | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 526abe69-4bbc-6e73-e063-6394a90ad25d | 2026-06-08 | Warnings | LIDOCAINE |
| Dcsily Numbing Cream | LIDOCAINE | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 53cab09c-6d5d-471e-e063-6294a90aa977 | 2026-06-08 | Warnings | LIDOCAINE |
| lidocaine | LIDOCAINE | Northstar Rx LLC | cde68b0c-a1ee-421d-9ca8-bc571d2990ab | 2026-06-08 | Warnings, Adverse reactions | LIDOCAINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.