Application 080210
- Type
- ANDA
- Sponsor
- BELMORA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE | LIDOCAINE | OINTMENT;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080210-001 | LIDOCAINE | LIDOCAINE | 5% | OINTMENT / TOPICAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080210-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | Approved before 1982 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Benco Dental | c5cc87df-df3f-42b8-af84-5f2045d42084 | 2026-07-30 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Benco Dental | 9419ac39-9b26-4cca-a2d6-167205fede24 | 2026-07-28 | Warnings, Adverse reactions | Lidocaine |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Patterson Dental | 6506755f-c9f7-4286-9ba7-ac5d5745f5e4 | 2026-07-28 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Darby Dental Supply, LLC | 27e8fdfb-e923-4f99-aff7-8b9e50228151 | 2026-07-27 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Darby Dental Supply, LLC | e5ed4c2a-e320-48cf-a2fd-61d48481c624 | 2026-07-27 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Patterson Dental | f074c0dc-7c3f-46fd-a480-b8337a19fe5c | 2026-07-27 | Warnings, Adverse reactions | Lidocaine |
| Lidfix Pain Relief Patch Lidocaine | LIDOCAINE | HETERO HEALTHCARE LIMITED | 2149f0e3-1983-4f02-929e-ecd20357f4bb | 2026-07-27 | Warnings | LIDOCAINE |
| RectoProtect | LIDOCAINE | Akron Pharma Inc. | 1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb | 2026-07-27 | Warnings | LIDOCAINE |
| NUMBING | LIDOCAINE | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 578675e8-30e7-6986-e063-6394a90a8afe | 2026-07-26 | Warnings | LIDOCAINE |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangdong Aimu Biological Technology Co., Ltd | 578fa642-ff30-e511-e063-6294a90a5987 | 2026-07-26 | Warnings | LIDOCAINE |
| Pain Relief Patch Lidocaine | LIDOCAINE | HyVee | 41c26a66-3371-2c2c-e063-6294a90aa38b | 2026-07-22 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Shaanxi Shuvita Biotech Co., Ltd | 572b95a1-11b2-6328-e063-6394a90acb73 | 2026-07-21 | Warnings | Lidocaine LIDOCAINE |
| RectaEase Hemorrhoid Relief Cream | LIDOCAINE | Trifecta Pharmaceuticals USA LLC | c054921a-9f1b-7c75-e053-2995a90a1738 | 2026-07-20 | Warnings | LIDOCAINE |
| VBBV Numbing | LIDOCAINE | Jiashen International Trade Limited | 5716c36b-6e97-c294-e063-6394a90aaf5c | 2026-07-20 | Warnings | LIDOCAINE |
| Burn Relief | LIDOCAINE | Premier Brands of America Inc. | 560c29cc-2453-5d14-e063-6394a90a844f | 2026-07-17 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | A-S Medication Solutions | 2bb5b298-3802-446c-b8cd-313e84bff04e | 2026-07-15 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | ASCLEMED USA INC. | 56a54ef4-7aa0-e181-e063-6394a90a3e0e | 2026-07-15 | Warnings, Adverse reactions | Lidocaine 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 |