Lidocaine

Product NDC
33261-564
11-digit product format
332610564
Labeler code
33261
Product ID
33261-564_3ad10c0b-4d0f-44dd-a9ca-9ed8289d52ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-564IInactivated by FDA2026-08-17
excluded packagepackage33261-56433261-564-01IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-564-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-564-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-564-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-564-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-564-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-564-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-564-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-564-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-564-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-564-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-564-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-564-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-564-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-564-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-564-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-564-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-564-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-564-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-564-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-564-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-564-019bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080198-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A080198-001AT

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A080198-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080198-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080198-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080198-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080198-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080198-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080198-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080198-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080198-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080198-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080198-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080198-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080198-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080198-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080198-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080198-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080198-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080198-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080198-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080198-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080198-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080198-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A080198-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080198-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080198-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080198-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A080198-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080198-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080198-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080198-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080198-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080198-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080198-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080198-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080198-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080198-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080198-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080198-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080198-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080198-001AT1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-564-012020-01-31C16284748780-19d75b9d0-75e2-f424-e053-dadaa90a57ceLIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-564-01Lidocaine35.44 g in 1 TUBEOINTMENT35.441
33261-564-01Lidocaine1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-564-01GM - Gram33261-564897ec665-e11a-469a-bd70-224a720c8c5b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQLIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-564LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140110_670287ac-9d8d-4514-b433-4adcca2d915a.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEFougera Pharmaceuticals, LLC88ca9cba-0c4a-482f-b502-ceefdb1bfbcd2026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080198
application number: ANDA080198

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 5 % Topical OintmentSY670287ac-9d8d-4514-b433-4adcca2d915a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-564-013326105640135.44 g in 1 TUBE35.44 gHistorical