Lidocaine

Product NDC
71335-1934
11-digit product format
713351934
Labeler code
71335
Product ID
71335-1934_7fb8b904-457f-44ec-95eb-d36704c4ebdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Bryant Ranch Prepack
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
65cf652c-87f2-43c6-a6f8-e4a83b42ce78Available 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
71335-1934-1Lidocaine1 g in 1 POUCHPATCH1102
71335-1934-1Lidocaine30 in 1 CARTONPATCH30102
71335-1934-2Lidocaine3 in 1 CARTONPATCH3102
71335-1934-2Lidocaine1 g in 1 POUCHPATCH1102
71335-1934-3Lidocaine9 in 1 CARTONPATCH9102
71335-1934-3Lidocaine1 g in 1 POUCHPATCH1102
71335-1934-4Lidocaine10 in 1 CARTONPATCH10102
71335-1934-4Lidocaine1 g in 1 POUCHPATCH1102
71335-1934-5Lidocaine1 g in 1 POUCHPATCH1102
71335-1934-5Lidocaine14 in 1 CARTONPATCH14102
71335-1934-6Lidocaine1 g in 1 POUCHPATCH1102
71335-1934-6Lidocaine5 in 1 CARTONPATCH5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1934-1EA - Each71335-1934dcbd8ad0-c897-4f98-a717-e9489378cd8c12024-02-14
71335-1934-3EA - Each71335-193422dcc28a-167b-4547-8ea8-d8790007929812024-02-14
71335-1934-5EA - Each71335-193458649c02-8a87-409f-b71d-579864bd02a612024-02-14
71335-1934-6EA - Each71335-193448fcced9-d0b7-4ae5-818c-c9f57be2a90712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1934LIDOCAINE PATCH [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 12 package rows20240125_65cf652c-87f2-43c6-a6f8-e4a83b42ce78.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
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
ndc (product): 71335-1934
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 PatchPSN65cf652c-87f2-43c6-a6f8-e4a83b42ce78102
1745091lidocaine 0.05 MG/MG Medicated PatchSCD65cf652c-87f2-43c6-a6f8-e4a83b42ce78102
1745091lidocaine 5 % Medicated PatchSY65cf652c-87f2-43c6-a6f8-e4a83b42ce78102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1934-17133519340130 POUCH in 1 CARTON (71335-1934-1) / 1 g in 1 POUCH30 pouch2021-08-190000-00-00NoNoCurrent
71335-1934-2713351934023 POUCH in 1 CARTON (71335-1934-2) / 1 g in 1 POUCH3 pouch2021-08-190000-00-00NoNoCurrent
71335-1934-3713351934039 POUCH in 1 CARTON (71335-1934-3) / 1 g in 1 POUCH9 pouch2021-08-190000-00-00NoNoCurrent
71335-1934-47133519340410 POUCH in 1 CARTON (71335-1934-4) / 1 g in 1 POUCH10 pouch2021-08-190000-00-00NoNoCurrent
71335-1934-57133519340514 POUCH in 1 CARTON (71335-1934-5) / 1 g in 1 POUCH14 pouch2021-08-190000-00-00NoNoCurrent
71335-1934-6713351934065 POUCH in 1 CARTON (71335-1934-6) / 1 g in 1 POUCH5 pouch2021-08-19NoNoCurrent