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 | REMEDYREPACK INC. | 9bf01533-ed83-4440-bdc4-4b45729bfc31 | 2026-06-05 | Warnings, Adverse reactions | LIDOCAINE |
| Adellina Lidocaine Numbing Cream Topical Anorectal Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 5356cf53-935d-a02f-e063-6394a90a6e5a | 2026-06-05 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Sun Pharmaceutical Industries, Inc. | 5eb2c62f-5352-41d7-bd66-c65b1988a9ab | 2026-06-03 | Warnings, Adverse reactions | LIDOCAINE |
| Biofreeze Ultraflex | LIDOCAINE | Reckitt Benckiser LLC | 2655974b-a67d-9f07-e063-6294a90a54e8 | 2026-06-02 | Warnings | LIDOCAINE |
| Healcome Lidocaine Numbing Cream | LIDOCAINE | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 9b4eac02-1b1f-4630-92b4-b1d8c21abab5 | 2026-05-29 | Warnings | LIDOCAINE |
| Aspercreme Lidocaine XL | LIDOCAINE | Lead Chemical Co., Ltd. | b1077b76-7ae7-4b1b-a972-c1b10e9671f9 | 2026-05-29 | Warnings | LIDOCAINE |
| Lidocaine Roll-on | LIDOCAINE | YYBA Corp | 52d060df-2095-dd68-e063-6394a90a7740 | 2026-05-27 | Warnings | LIDOCAINE |
| MyDerm Medical 5 Lidocaine Numbing Roll-On | LIDOCAINE | Inspec Solutions | 1d466be1-a780-462f-8dd4-87478da096aa | 2026-05-27 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Par Health USA, LLC | 2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc | 2026-05-27 | Warnings, Adverse reactions | LIDOCAINE |
| MyDerm Aloe and Lidocaine | LIDOCAINE | Medline Industries | fdfd4388-cd27-467b-959b-249a49ea5cf6 | 2026-05-26 | Warnings | LIDOCAINE |
| MyDerm Aloe and Lidocaine | LIDOCAINE | Inspec Solutions LLC. | 4939c663-a876-4527-822a-df02964fa694 | 2026-05-26 | Warnings | LIDOCAINE |
| lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | 54df7353-5411-43ad-bd7b-a3d4d62c72c6 | 2026-05-21 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | 4806f94d-cbac-4107-b93b-8f715868ffb3 | 2026-05-21 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c | 2026-05-21 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | 323e0ec2-c2e5-47d1-a39f-69ff5c99e324 | 2026-05-21 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine Pain Relief Patch | LIDOCAINE | GERI-CARE PHARMACEUTICAL CORP | 522f1521-f9f2-4c26-e063-6394a90a9e05 | 2026-05-19 | Warnings | LIDOCAINE |
| Burn Relief | LIDOCAINE | WALMART INC. | 15af4557-4baf-c177-e063-6294a90a7a5b | 2026-05-18 | Warnings | LIDOCAINE |
| LIDOCAINE PAIN RELIEF Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 01ff3442-5a4e-4013-e063-6294a90a809e | 2026-05-17 | Warnings | LIDOCAINE |
| LIDOCAINE PAIN RELIEF Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 247ecba5-196b-0179-e063-6394a90a0371 | 2026-05-17 | Warnings | LIDOCAINE |
| LIDOCAINE PAIN RELIEF Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 322aa97d-b35b-d9dd-e063-6394a90a7ae5 | 2026-05-17 | Warnings | LIDOCAINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.