Lidocaine and Prilocaine

Product NDC
52565-007
Requested package NDC
52565-007-30
11-digit product format
525650007
Labeler code
52565
Product ID
52565-007_de4a6eae-ba69-4f23-9cb1-9a827cbdbd6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA205887
Marketing category
ANDA
Marketing start
2018-06-29
Marketing end
0000-00-00
Substance
LIDOCAINE; PRILOCAINE
Active strength
25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],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 packagepackage52565-00752565-007-30IInactivated 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 packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-00752565-007-30IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-00752565-007-30IInactivated 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
A205887-001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-29

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 UTC2026-02A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2018-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205887-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2018-06-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205887-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205887-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205887-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205887-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205887-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205887-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205887-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205887-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205887-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205887-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205887-001AB1301d65b070ca…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205887-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205887-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205887-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205887-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205887-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205887-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205887-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205887-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205887-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205887-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205887-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205887-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205887-001AB1ea99ee380514…
2023-05-13 08:27 UTC2023-05A205887-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205887-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205887-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205887-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205887-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205887-001AB1cb3db0bc1861…

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
52565-007-072023-01-30C16284748780-1f386c64a-3e26-0266-e053-dadaa90a7c1aLidocaine and Prilocaine USP, 2.5%/2.5%
52565-007-302023-01-30C16284748780-1f386c64a-3e26-0266-e053-dadaa90a7c1aLidocaine and Prilocaine USP, 2.5%/2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-007-07Lidocaine and Prilocaine5 in 1 CARTONCREAM53
52565-007-07Lidocaine and Prilocaine5 g in 1 TUBECREAM53
52565-007-30Lidocaine and Prilocaine1 in 1 CARTONCREAM13
52565-007-30Lidocaine and Prilocaine30 g in 1 TUBECREAM303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-007-07GM - Gram52565-007debcb466-ce7a-4db5-a4f8-4c4ede69bee112018-12-13
52565-007-30GM - Gram52565-0078b71ed7d-d313-4bb5-9a5d-f531d6636dc012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-007LIDOCAINE AND PRILOCAINE CREAM [TELIGENT PHARMA, INC.]3Legacy NDC, 4 package rows20181121_7a790e8b-ff12-411f-bacc-9141d4dfef58.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
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINEPAI Holdings, LLC dba PAI Pharma58204dfe-f18d-41c4-80e4-eae54fe8d5832025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205887
application number: ANDA205887

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN7a790e8b-ff12-411f-bacc-9141d4dfef583
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD7a790e8b-ff12-411f-bacc-9141d4dfef583
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY7a790e8b-ff12-411f-bacc-9141d4dfef583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-007-30525650007301 TUBE in 1 CARTON (52565-007-30) > 30 g in 1 TUBE1 tube2018-06-290000-00-00NoNoCurrent