LIDOCAINE

Product NDC
61919-588
11-digit product format
619190588
Labeler code
61919
Product ID
61919-588_4d3a653e-054d-4554-e063-6294a90a1239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE
Dosage form
PATCH
Route
CUTANEOUS
Labeler
DIRECT RX
Application
NDA020612
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-05-12
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
2027-12-31
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-588-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-588-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-588-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-588-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-588-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-588-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-588-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-588-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-588-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

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
a575bcb8-478f-1f7e-e053-2995a90a4b12Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-588-302025-01-30C16284748780-12cef2736-6515-d83d-e063-dadaa90ab31fLIDOCAINE PATCHES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-588-30LIDOCAINE1 g in 1 CARTONPATCH12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-588-30EA - Each61919-588d8563a38-bbdd-4510-aa5e-3b6139932fb412020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-588LIDOCAINE PATCH [DIRECT RX]1Current NDC, Legacy NDC, 1 package rows20200513_a575bcb8-478f-1f7e-e053-2995a90a4b12.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 · 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
ndc (product): 61919-588
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
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 PatchPSNa575bcb8-478f-1f7e-e053-2995a90a4b122
1745091lidocaine 0.05 MG/MG Medicated PatchSCDa575bcb8-478f-1f7e-e053-2995a90a4b122
1745091lidocaine 5 % Medicated PatchSYa575bcb8-478f-1f7e-e053-2995a90a4b122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-588-30619190588301 g in 1 CARTON (61919-588-30) 1 g2020-05-120000-00-00NoNoCurrent