Application 211019
- Type
- ANDA
- Sponsor
- ACP NIMBLE
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 |
|---|---|---|---|---|---|---|---|
| A211019-001 | LIDOCAINE | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | 2018-12-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A211019-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | 2018-12-12 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211019-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A211019-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A211019-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A211019-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A211019-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A211019-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211019-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A211019-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A211019-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A211019-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A211019-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A211019-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A211019-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211019-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A211019-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A211019-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211019-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211019-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211019-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211019-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A211019-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A211019-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211019-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A211019-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A211019-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211019-001 | AT | 1 | 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 |
|---|---|---|---|---|---|---|
| Lidocaine | LIDOCAINE | Amneal Pharmaceuticals LLC | 960f6d0a-82af-45e9-89d5-cea808004ebb | 2026-08-25 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Big Toe Joint Pain Relief Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c8ff98-55c7-796d-e063-6394a90af73a | 2026-08-24 | Warnings | LIDOCAINE |
| NERANTE Numbing Cream | LIDOCAINE | Guangdong Quadrant Ecological Technology Co., Ltd. | 4dacd4f1-24d8-37ab-e063-6294a90a944d | 2026-08-21 | Warnings | LIDOCAINE |
| Lidocaine Numbing Cream | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 599b425a-0e96-76df-e063-6394a90a48ff | 2026-08-21 | Warnings | LIDOCAINE |
| Rugby PAIN RELIEF PATCHES | LIDOCAINE | RUGBY LABORATORIES | b34e40c8-a257-46cf-9399-f55df9b4102d | 2026-08-20 | Warnings | LIDOCAINE |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | LIDOCAINE |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | Warnings | LIDOCAINE |
| Gembooxt Topical Numbing Cream | LIDOCAINE | Guangdong Quadrant Ecological Technology Co., Ltd. | 49951a3e-3b62-3d66-e063-6294a90a9360 | 2026-08-12 | Warnings | LIDOCAINE |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 | 2026-08-12 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Sentiss Pharmaceuticals LLC | 9b2d4f69-0c84-4956-b5c0-b4410acf62e0 | 2026-08-12 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | 864e511b-cc50-4ed9-b122-8e1a93457332 | 2026-08-11 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | The Atlanta Dental Supply Company DBA Advanced Dental Products | 55030c51-250b-4fc2-ba3c-ac38dab7cc8e | 2026-08-10 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | df130310-41db-45df-a214-9da01cf0bf41 | 2026-08-10 | Warnings, Adverse reactions | Lidocaine |
| Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing | LIDOCAINE | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 4a7be9eb-5e57-90e8-e063-6394a90aad9e | 2026-08-08 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Ascend Laboratories, LLC | 67a6bbbd-ab4b-414a-b85c-b7d8c0cfa9d2 | 2026-08-06 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | NDC, Inc. | 937e9341-e604-4ca7-98e1-fc7c659d82e9 | 2026-08-06 | Warnings, Adverse reactions | LIDOCAINE |
| Dealmed Burn | LIDOCAINE | Dealmed Medical Supplies, LLC. | 3b5f7ded-c275-4d7f-9fd4-539797d5507e | 2026-08-05 | Warnings | LIDOCAINE |
| Lidocaine Plantar Relief Roll-On | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 585ccb4b-3bff-39b9-e063-6294a90a0e18 | 2026-08-05 | Warnings | LIDOCAINE |
| Lidocaine Numbing Cream | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 5457b3d7-e6b6-34a7-e063-6394a90aa240 | 2026-08-03 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | PHOENIX RX LLC | 57edfcb8-272c-8af4-e063-6294a90ae2e5 | 2026-07-31 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |