Lidocaine

Product NDC
55700-025
Requested package NDC
55700-025-30
11-digit product format
557000025
Labeler code
55700
Product ID
55700-025_3529e253-f44d-495a-bf0c-f4ca6d50829d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA200675
Marketing category
ANDA
Marketing start
2013-09-15
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 packagepackage55700-02555700-025-30DDiscontinued by firm2026-08-11

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…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
A200675-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2012-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200675-001AB

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 UTC2026-02A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200675-001LIDOCAINE5%PATCH / TOPICALAB2012-08-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200675-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200675-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200675-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200675-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200675-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200675-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200675-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200675-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200675-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200675-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200675-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200675-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200675-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200675-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200675-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200675-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200675-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200675-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200675-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200675-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200675-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200675-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200675-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200675-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200675-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200675-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200675-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200675-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200675-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200675-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200675-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200675-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200675-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200675-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200675-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200675-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200675-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200675-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200675-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200675-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-025-302025-01-08C16284748780-1f386c649-f366-0266-e053-dadaa90a7c1aLidocaine Patch
55700-025-302023-01-30C16284748780-1f386c649-f366-0266-e053-dadaa90a7c1aLidocaine Patch

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-025-30EA - Each55700-025b62de8aa-cdb1-4e68-b836-47b0ec5224fe12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
KAOLININACTIVE INGREDIENT24H4NWX5COLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
UREAINACTIVE INGREDIENT8W8T17847WLIDOCAINE PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tridacaine IILIDOCAINETrifluent Pharma LLC1e940ba6-3916-4fc4-8886-481fc9685fc12026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEPureTek Corporation85e72943-6989-42f4-b519-a3ebbf4bc7772025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINECardinal Health 107, LLCeb808fdf-0420-45e9-ad17-8380d49d5c212025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEActavis Pharma, Inc.c18799cd-9e11-4196-9ab1-0a2a84585e562025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEBryant Ranch Prepack4e856dd5-f2fa-4acb-a205-f87baf26b8cc2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEBryant Ranch Prepack1d28d687-695e-4cd9-97e2-7d4fdab9772a2024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEBryant Ranch Prepack6d7fdc43-e493-449e-9af6-825e584b547a2023-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEAsclemed USA, Inc.80dadfb5-cbe6-475f-9980-a1b2559827532022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEActavis Pharma, Inc.4d04052c-3e0a-469a-9265-99604f13e5072022-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675
LidocaineLIDOCAINEAVKAREec6a4720-9821-c0fc-e053-2995a90a05df2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200675
application number: ANDA200675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-025-305570000253030 POUCH in 1 CARTON (55700-025-30) > 1 g in 1 POUCH30 pouch2013-09-150000-00-00NoNoCurrent