LIDOCAINE PATCH 5%

Manufacturer
DIRECT RX
Effective date
2016-03-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:22:09

Label at a glance#

ProductLIDOCAINE
Active ingredientLIDOCAINE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIDOCAINE PATCHLIDOCAINE PATCH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1745091lidocaine 5 % Medicated PatchPSN1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1
1745091lidocaine 5 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-779-30LIDOCAINE30 in 1 CARTONPATCH301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-779LIDOCAINE PATCH [DIRECT RX]11 package rows20160331_2f1e77e1-86b6-635e-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-779-30EA - Each61919-7796e2c5d22-27e7-4c2e-b24d-acc6f7a6e42212016-09-02
0603-1880-10EA - Each0603-1880058e9b98-afdb-4273-b0c5-0b8fa1489d4812014-06-03
0603-1880-16EA - Each0603-188074899f72-596e-4b3e-a772-efbc3e7d0e7f12014-06-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-77961919-779-30
0603-1880

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-1984e616aacf4f…
2026-08-18 06:07:402026-07N020612-001LIDODERM5%PATCH / TOPICALABRLD, RS1999-03-19caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020612-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N020612-001AB1caaa826d4ba7…
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…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEPar Health USA, LLC2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc2026-05-27Warnings, Adverse reactionsExact identifier
ndc (product): 0603-1880
2f1e77e1-86b7-635e-e054-00144ff88e882f1e77e1-86b6-635e-e054-00144ff88e882016-03-28Warnings, Adverse reactionsExact identifier
spl id: 2f1e77e1-86b7-635e-e054-00144ff88e88
spl set id: 2f1e77e1-86b6-635e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.