Lidocaine

Product NDC
55154-7228
11-digit product format
551547228
Labeler code
55154
Product ID
55154-7228_a2f7ab94-1f3f-4e8c-92c5-a1f059d7acb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
NDA020612
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-05-02
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
2026-12-31
Current FDA listing
Yes

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
2026-12-31

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
fa69dfdf-ab73-48a9-944d-25e88d7766dfAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7228-5Lidocaine5 in 1 BAGPATCH510
55154-7228-5Lidocaine0.7 g in 1 POUCHPATCH0.710

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE PATCH [CARDINAL HEALTH]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE PATCH [CARDINAL HEALTH]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE PATCH [CARDINAL HEALTH]1
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6LIDOCAINE PATCH [CARDINAL HEALTH]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOCAINE PATCH [CARDINAL HEALTH]1
GELATININACTIVE INGREDIENT2G86QN327LLIDOCAINE PATCH [CARDINAL HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE PATCH [CARDINAL HEALTH]1
KAOLININACTIVE INGREDIENT24H4NWX5COLIDOCAINE PATCH [CARDINAL HEALTH]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE PATCH [CARDINAL HEALTH]1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WLIDOCAINE PATCH [CARDINAL HEALTH]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDOCAINE PATCH [CARDINAL HEALTH]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE PATCH [CARDINAL HEALTH]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE PATCH [CARDINAL HEALTH]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JLIDOCAINE PATCH [CARDINAL HEALTH]1
SORBITOLINACTIVE INGREDIENT506T60A25RLIDOCAINE PATCH [CARDINAL HEALTH]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDOCAINE PATCH [CARDINAL HEALTH]1
UREAINACTIVE INGREDIENT8W8T17847WLIDOCAINE PATCH [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7228LIDOCAINE PATCH [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250110_fa69dfdf-ab73-48a9-944d-25e88d7766df.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
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
ndc (product): 55154-7228
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 PatchPSNfa69dfdf-ab73-48a9-944d-25e88d7766df10
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfa69dfdf-ab73-48a9-944d-25e88d7766df10
1745091lidocaine 5 % Medicated PatchSYfa69dfdf-ab73-48a9-944d-25e88d7766df10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7228-5551547228055 POUCH in 1 BAG (55154-7228-5) / .7 g in 1 POUCH5 pouch2014-05-020000-00-00NoNoCurrent