Lidocaine
- Product NDC
- 0168-0204
- 11-digit product format
- 001680204
- Labeler code
- 0168
- Product ID
- 0168-0204_76e9f389-e9f0-4568-8b13-74c9dd831001
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Fougera Pharmaceuticals, LLC
- Application
- ANDA080198
- Marketing category
- ANDA
- Marketing start
- 1972-06-30
- Substance
- LIDOCAINE
- Active strength
- 50 mg/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 0168-0204 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lidocaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE | 50 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 98PI200987 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1543069 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd | Available on FDA.report |
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 |
|---|---|---|---|---|---|
| 0168-0204-37 | 2021-01-25 | C162847 | 48780-1 | ab0e2407-347f-f274-e053-dbdaa90a6471 | LIDOCAINE OINTMENT USP, 5% |
| 0168-0204-37 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-347f-f274-e053-dbdaa90a6471 | LIDOCAINE OINTMENT USP, 5% |
| 0168-0204-37 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-347f-f274-e053-dbdaa90a6471 | LIDOCAINE OINTMENT USP, 5% |
| 0168-0204-37 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-347f-f274-e053-dbdaa90a6471 | LIDOCAINE OINTMENT USP, 5% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0168-0204-37 | Lidocaine | 35.44 g in 1 TUBE | OINTMENT | 35.44 | 11 | |
| 0168-0204-37 | Lidocaine | 1 in 1 CARTON | OINTMENT | 1 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0204-37 | GM - Gram | 0168-0204 | 35c62859-1d06-4f09-93c7-61d8ac84ca78 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1543069 | lidocaine 5 % Topical Ointment | PSN | 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd | 11 |
| 1543069 | lidocaine 0.05 MG/MG Topical Ointment | SCD | 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd | 11 |
| 1543069 | lidocaine 5 % Topical Ointment | SY | 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd | 11 |
| 1543069 | lidocaine 5 % Topical Ointment | PSN | 670287ac-9d8d-4514-b433-4adcca2d915a | 1 |
| 1543069 | lidocaine 5 % Topical Ointment | PSN | a1e2c14f-0682-4b19-9159-de0aca1960c6 | 1 |
| 1543069 | lidocaine 0.05 MG/MG Topical Ointment | SCD | 670287ac-9d8d-4514-b433-4adcca2d915a | 1 |
| 1543069 | lidocaine 0.05 MG/MG Topical Ointment | SCD | a1e2c14f-0682-4b19-9159-de0aca1960c6 | 1 |
| 1543069 | lidocaine 5 % Topical Ointment | SY | 670287ac-9d8d-4514-b433-4adcca2d915a | 1 |
| 1543069 | lidocaine 5 % Topical Ointment | SY | a1e2c14f-0682-4b19-9159-de0aca1960c6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0204-37 | 00168020437 | 1 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE | 1 tube | 1972-06-30 | 0000-00-00 | No | No | Current |