Lidocaine
- Product NDC
- 21695-826
- 11-digit product format
- 216950826
- Labeler code
- 21695
- Product ID
- 21695-826_a1e2c14f-0682-4b19-9159-de0aca1960c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA080198
- Marketing category
- ANDA
- Marketing start
- 1972-06-30
- Marketing end
- 0000-00-00
- Substance
- LIDOCAINE
- Active strength
- 50 mg/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 21695-826 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | ||
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | ||
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | ||
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | ||
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | ||
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | ||
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | ||
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… | ||
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… | ||
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | ||
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 9bebd1f3094a… | 5416666fcb17… | ||
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 9bebd1f3094a… | 5416666fcb17… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 21695-826 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 21695-826 | 21695-826-35 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080198-001 | LIDOCAINE | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A080198-001 | AT |
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 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RS, Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080198-001 | LIDOCAINE | 5% | OINTMENT / TOPICAL | AT | RLD, RS, Approved before 1982 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A080198-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080198-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A080198-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080198-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080198-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080198-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080198-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080198-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080198-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A080198-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080198-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080198-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080198-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A080198-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080198-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A080198-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A080198-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A080198-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A080198-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A080198-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080198-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A080198-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A080198-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A080198-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A080198-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A080198-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A080198-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080198-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A080198-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A080198-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080198-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080198-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080198-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080198-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A080198-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A080198-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080198-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A080198-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A080198-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080198-001 | AT | 1 | cb3db0bc1861… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lidocaine | LIDOCAINE | Fougera Pharmaceuticals, LLC | 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd | 2026-01-28 | Warnings, Adverse reactions | 080198 ANDA080198 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-826-35 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4af1-48b1-e053-8cdaa90a720a | LIDOCAINE OINTMENT USP, 5% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-826-35 | Lidocaine | 35 g in 1 TUBE | OINTMENT | 35 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| lidocaine | ACTIVE INGREDIENT | 98PI200987 | LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| lidocaine | ACTIVE MOIETY | 98PI200987 | LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| polyethylene glycol 1450 | INACTIVE INGREDIENT | OJ4Z5Z32L4 | LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| polyethylene glycol 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1543069 | lidocaine 5 % Topical Ointment | PSN | a1e2c14f-0682-4b19-9159-de0aca1960c6 | 1 |
| 1543069 | lidocaine 0.05 MG/MG Topical Ointment | SCD | a1e2c14f-0682-4b19-9159-de0aca1960c6 | 1 |
| 1543069 | lidocaine 5 % Topical Ointment | SY | a1e2c14f-0682-4b19-9159-de0aca1960c6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-826-35 | 21695082635 | 35 g in 1 TUBE | 35 g | Historical |