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 | Bryant Ranch Prepack | 19c585f3-e635-44d4-8eb0-14529eb34dca | 2024-04-03 | Warnings, Adverse reactions | LIDOCAINE |
| Meijer Pain Relief Cream | LIDOCAINE | Meijer Distribution | 07ecee44-387a-cdce-e063-6294a90ab9c9 | 2024-03-27 | Warnings | LIDOCAINE |
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | LIDOCAINE |
| XYLOCAINE | XYLOCAINE | HF Acquisition Co LLC, DBA HealthFirst | e3b3b462-8f35-68b8-e053-2995a90a6403 | 2024-01-27 | Warnings, Adverse reactions | XYLOCAINE |
| Aspercreme | LIDOCAINE | Lead Chemical Co. Ltd. | 275e1343-deef-424a-a883-5e780083af91 | 2024-01-25 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Bryant Ranch Prepack | 65cf652c-87f2-43c6-a6f8-e4a83b42ce78 | 2024-01-24 | Warnings, Adverse reactions | LIDOCAINE |
| XYLOCAINE | XYLOCAINE | HF Acquisition Co LLC, DBA HealthFirst | 0c6c5678-e987-b822-e063-6394a90ac88b | 2024-01-22 | Warnings, Adverse reactions | XYLOCAINE |
| Burn | LIDOCAINE | HART Health | e95ebdac-9789-41c2-97da-2307e4538794 | 2024-01-18 | Warnings | LIDOCAINE |
| CVS Health Lidocaine Pain Relief | LIDOCAINE | Natural Essentials, Inc. | 52e82e70-53b7-4ecb-be39-fe10c94cc444 | 2024-01-17 | Warnings | LIDOCAINE |
| CVS Health XL Lidocaine Pain Relief | LIDOCAINE | NATURAL ESSENTIALS, INC. | ec16da91-8244-402b-b8d8-84896094ac2c | 2024-01-17 | Warnings | LIDOCAINE |
| Salonpas Pain Relieving LIDOCAINE 4% FLEX | LIDOCAINE | Hisamitsu Pharmaceutical Co., Inc. | 9507f727-c49f-4de4-9d64-b6d977d568ab | 2024-01-17 | Warnings | LIDOCAINE |
| Lightning X Burn | LIDOCAINE | Nantong Health & Beyond Hygienic Products Inc. | 0e69a971-0c6e-6ebe-e063-6394a90a0b33 | 2024-01-08 | Warnings | LIDOCAINE |
| Lidocaine Numbing Cream | LIDOCAINE | YYBA Corp | de6dc194-c6ef-4cb5-be3f-e772ace9abaf | 2024-01-03 | Warnings | LIDOCAINE |
| Bactine Max Bandage | LIDOCAINE | WellSpring Pharmaceutical Corporation | 465dc46e-6435-4569-9516-f648d0fe0f09 | 2023-12-21 | Warnings | LIDOCAINE |
| Greencaine Blast | LIDOCAINE | ALMA Laboratories, Inc. | 031e0065-4c8a-43d8-bc69-3efa3c6c0ae3 | 2023-12-12 | Warnings | LIDOCAINE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE | A-S Medication Solutions | 38610ee9-4e70-4a8a-a5c5-6c148cf145f0 | 2023-12-04 | Warnings, Adverse reactions | Xylocaine |
| Prolayed Lidocaine Male Genital Desensitizer | LIDOCAINE | ViaDerma Distribution, Inc. | 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f | 2023-12-02 | Warnings | LIDOCAINE |
| Prolayed | LIDOCAINE | MATRIX MIXOLOGY, INC | ae317876-adb1-6d13-e053-2995a90a74af | 2023-12-01 | Warnings | LIDOCAINE |
| Bloop Fissure Healing Anorectal Topical | LIDOCAINE | Three Nations Corp | 0b645092-ebc4-e4bb-e063-6294a90ad4cf | 2023-11-30 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Bryant Ranch Prepack | 6d7fdc43-e493-449e-9af6-825e584b547a | 2023-11-16 | Warnings, Adverse reactions | LIDOCAINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.