Lidocaine

Product NDC
52565-008
Requested package NDC
52565-008-55
11-digit product format
525650008
Labeler code
52565
Product ID
52565-008_528ee36a-310d-473c-b560-f1abe3d6c865
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA205318
Marketing category
ANDA
Marketing start
2017-02-27
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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52565-00852565-008-55IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-00852565-008-55IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205318-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205318-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205318-001LIDOCAINE5%OINTMENT / TOPICAL2016-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205318-001LIDOCAINE5%OINTMENT / TOPICALAT2016-02-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205318-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205318-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205318-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205318-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205318-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205318-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205318-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A205318-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205318-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205318-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205318-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A205318-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205318-001AT1ea99ee380514…
2023-05-13 08:27 UTC2023-05A205318-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205318-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205318-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205318-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205318-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205318-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205318-001AT1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDICAINEEncube Ethicals, Inc.e9f80c8a-05ba-47f8-aff1-e2583b2f8e572026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205318
application number: ANDA205318
LidocaineLIDOCAINEAsclemed USA, Inc.c18f0c2b-cd05-4458-888f-47b4a11069372020-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205318
application number: ANDA205318
LidocaineLIDOCAINEProficient Rx LPcbf01b82-c43f-4bed-a1df-7569f4816c762019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205318
application number: ANDA205318

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
52565-008-142023-01-30C16284748780-1f386c64a-1b99-0266-e053-dadaa90a7c1aLIDOCAINE OINTMENT USP, 5%
52565-008-552023-01-30C16284748780-1f386c64a-1b99-0266-e053-dadaa90a7c1aLIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-008-14Lidocaine1 in 1 CARTONOINTMENT16
52565-008-14Lidocaine35.44 g in 1 TUBEOINTMENT35.446
52565-008-55Lidocaine50 g in 1 JAROINTMENT506
52565-008-55Lidocaine1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-008-14GM - Gram52565-008cee9d3df-bb17-401e-adfb-1a30da69189112016-04-04
52565-008-55GM - Gram52565-008d1aff958-0052-4ed8-9e28-b35a2e4603dd12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-008LIDOCAINE (LIDOCAINE) OINTMENT [TELIGENT PHARMA, INC.]6Legacy NDC, 4 package rows20181121_12639881-632d-445d-9ff5-b84567f49179.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN12639881-632d-445d-9ff5-b84567f491796
1543069lidocaine 0.05 MG/MG Topical OintmentSCD12639881-632d-445d-9ff5-b84567f491796
1543069lidocaine 5 % Topical OintmentSY12639881-632d-445d-9ff5-b84567f491796
1543069lidocaine 5 % Topical OintmentPSN857bf526-ab2a-b173-e053-2991aa0a04cf3
1543069lidocaine 0.05 MG/MG Topical OintmentSCD857bf526-ab2a-b173-e053-2991aa0a04cf3
1543069lidocaine 5 % Topical OintmentSY857bf526-ab2a-b173-e053-2991aa0a04cf3
1543069lidocaine 5 % Topical OintmentPSNa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 5 % Topical OintmentPSNcbf01b82-c43f-4bed-a1df-7569f4816c762
1543069lidocaine 0.05 MG/MG Topical OintmentSCDa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDcbf01b82-c43f-4bed-a1df-7569f4816c762
1543069lidocaine 5 % Topical OintmentSYa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 5 % Topical OintmentSYcbf01b82-c43f-4bed-a1df-7569f4816c762
1543069lidocaine 5 % Topical OintmentPSN2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 5 % Topical OintmentPSNbc028dba-b823-0eeb-e053-2a95a90a79051
1543069lidocaine 5 % Topical OintmentPSNc18f0c2b-cd05-4458-888f-47b4a11069371
1600976menthol 10 % Topical SolutionPSN2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 0.05 MG/MG Topical OintmentSCDbc028dba-b823-0eeb-e053-2a95a90a79051
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc18f0c2b-cd05-4458-888f-47b4a11069371
1600976menthol 100 MG/ML Topical SolutionSCD2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 5 % Topical OintmentSY2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 5 % Topical OintmentSYbc028dba-b823-0eeb-e053-2a95a90a79051
1543069lidocaine 5 % Topical OintmentSYc18f0c2b-cd05-4458-888f-47b4a11069371
1600976menthol 10 % Topical SolutionSY2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-008-55525650008551 JAR in 1 CARTON (52565-008-55) > 50 g in 1 JAR1 jar2017-07-170000-00-00NoNoCurrent