Lidocaine

Product NDC
70518-0566
11-digit product format
705180566
Labeler code
70518
Product ID
70518-0566_2e1e8839-a582-e2c5-e063-6294a90a70da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
REMEDYREPACK INC.
Application
NDA020612
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-02
Marketing end
2027-03-31
Substance
LIDOCAINE
Active strength
50 mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Current FDA listing
Yes

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0566-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0566-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0566-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0566-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0566-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0566-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0566-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0566-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0566-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0566-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0566-0557ba5c1ecfa…9c80585c8c6e…

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
N020612-001LIDODERMLIDOCAINE5%PATCH / TOPICALABRLD, RS1999-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020612-001AB

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 UTC2026-02N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19cb3db0bc1861…

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 UTC2026-02N020612-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020612-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020612-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020612-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020612-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020612-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020612-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020612-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020612-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020612-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020612-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020612-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020612-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020612-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020612-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020612-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020612-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020612-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020612-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020612-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020612-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020612-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020612-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020612-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020612-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020612-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020612-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020612-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020612-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020612-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020612-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020612-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020612-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020612-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020612-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020612-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020612-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020612-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020612-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020612-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1745091Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
94ab1b99-e203-4a14-b852-42d3b37999c3Available on FDA.report

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0566-0Lidocaine30 in 1 CARTONPATCH305

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINESt. Mary's Medical Park Pharmacy9dc3059c-3a3d-5810-e053-2a95a90ab0ba2026-06-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEGolden State Medical Supply, Inc.0bef12dd-6cea-d12b-e063-6394a90a002e2026-06-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEPar Health USA, LLC2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc2026-05-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEPreferred Pharmaceuticals Inc.323e0ec2-c2e5-47d1-a39f-69ff5c99e3242026-05-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LIDOCAINELIDOCAINEDIRECT RXa575bcb8-478f-1f7e-e053-2995a90a4b122026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINESportpharm LLC4611f0da-a41d-4861-9dd6-f16f1b007d332026-02-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEPHOENIX RX LLC3c69e03c-e176-2c23-e063-6394a90aa41f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEREMEDYREPACK INC.0748b9e3-1247-4eeb-8158-3d641b2ad85d2025-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEA-S Medication Solutionse23a92e6-3445-4ba7-9ad2-86a3eec1717e2025-08-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINECardinal Health 107, LLCfa69dfdf-ab73-48a9-944d-25e88d7766df2025-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEREMEDYREPACK INC.94ab1b99-e203-4a14-b852-42d3b37999c32025-02-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
ndc (product): 70518-0566
LidocaineLIDOCAINEAsclemed USA, Inc.f7ada189-7463-4bc7-83e7-f140558ecacf2024-12-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEQuality Care Products LLCf20ab860-e49a-4f3f-868e-6a60780af5a72024-12-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC1b561cc6-1d36-e259-e063-6294a90aacbd2024-06-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LidocaineLIDOCAINEBryant Ranch Prepack65cf652c-87f2-43c6-a6f8-e4a83b42ce782024-01-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612
LIDODERMLIDOCAINE PATCH 5%TPU Pharma, Inc.db0092f5-02a0-4076-ac32-969f075a6ab12022-12-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 020612
application number: NDA020612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN94ab1b99-e203-4a14-b852-42d3b37999c35
1745091lidocaine 0.05 MG/MG Medicated PatchSCD94ab1b99-e203-4a14-b852-42d3b37999c35
1745091lidocaine 5 % Medicated PatchSY94ab1b99-e203-4a14-b852-42d3b37999c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0566-07051805660030 PATCH in 1 CARTON (70518-0566-0) 30 patch2018-01-022027-03-31NoNoHistorical