Lidocan

Product NDC
59088-905
11-digit product format
590880905
Labeler code
59088
Product ID
59088-905_48891c0c-2eb2-a114-e063-6294a90a61bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine 5%
Dosage form
PATCH
Route
TOPICAL
Labeler
PURETEK CORPORATION
Application
ANDA209190
Marketing category
ANDA
Marketing start
2020-05-14
Substance
LIDOCAINE
Active strength
700 mg/1
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59088-905-54ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59088-905-540efc9e666f02…f202fb6c5f17…

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
A209190-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2020-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209190-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209190-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A209190-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209190-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209190-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209190-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209190-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209190-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209190-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209190-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209190-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209190-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209190-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209190-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209190-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209190-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209190-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209190-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209190-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209190-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209190-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209190-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209190-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209190-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209190-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209190-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209190-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209190-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209190-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209190-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209190-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209190-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209190-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209190-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209190-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209190-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209190-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209190-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209190-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209190-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE700 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1745091Internal RxNorm lookup
2642344Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd8e4856-3785-4850-e053-6294a90a95b6Available 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
59088-905-54Xyliderm30 in 1 PACKAGEPATCH700 mg5
59088-905-84Xyliderm1 in 1 POUCHPATCH1700 mg5
59088-905-54Lidocan30 in 1 PACKAGEPATCH303
59088-905-82Lidocan15 in 1 PACKAGEPATCH153
59088-905-84Lidocan1 in 1 POUCHPATCH13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-905-54EA - Each59088-905c5e9d08a-f1ad-46ca-aa96-1216d36ea1ed12023-08-08
59088-905-82EA - Each59088-9057958a40d-747a-4914-bcac-c64c9aae397812026-02-05
59088-905-84EA - Each59088-905b06ce429-ae67-4dcf-b49b-7bf768f9b0bc12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-905XYLIDERM (LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]5Current NDC20241215_fed45e06-cc4d-fbc5-e053-6294a90a1b19.zip
59088-905LIDOCAN (LIDOCAINE 5%) PATCH [PURETEK CORPORATION]2Current NDC, 3 package rows20250130_fd8e4856-3785-4850-e053-6294a90a95b6.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
Lidocaine 5%LIDOCAINE 5%A-S Medication Solutionsfec1e759-60e4-47d4-bd54-947f18b103dd2026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%St. Mary's Medical Park Pharmacy052fa8a3-0e3c-d9c2-e063-6394a90aadd72026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidox 5 PatchLIDOCAINE 5% PATCHInjecta Medcial LLC526b8681-098f-3410-e063-6294a90a79fb2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%YARAL Pharma Inc.fc495fc8-15d6-27c7-e053-6394a90ab30d2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
LidocanLIDOCAINE 5%PURETEK CORPORATIONfd8e4856-3785-4850-e053-6294a90a95b62026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
ndc (product): 59088-905
Lidocaine 5% PatchLIDOCAINE 5%Medcore LLC1afe428f-e223-4ef8-a6ba-968f4cfbf4762026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Tridacaine IIILIDOCAINETrifluent Pharma LLC9b47102e-3b35-4aa7-a380-cd02ba9eac652025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Tridacaine XLLIDOCAINETrifluent Pharma LLC032b37a7-8a47-4809-a330-c76314225cbd2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%REMEDYREPACK INC.50152ae0-aebd-4a08-a5c7-c8858e0259972025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%Asclemed USA, Inc.1dca5b81-72a9-4969-8552-d43091f72aab2025-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VILIDOCAINE 5%PURETEK CORPORATION1b6dc518-a15b-1cf9-e063-6294a90a63572024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VIILIDOCAINE 5%PURETEK CORPORATION1f33d51c-168c-55f2-e063-6394a90a89052024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan IVLIDOCAINE 5%PURETEK CORPORATION137f9cc1-68c0-edcc-e063-6394a90abf6a2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VLIDOCAINE 5%PURETEK CORPORATION141fe2bd-b25a-eff8-e063-6294a90a2ae82024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan IIILIDOCAINE 5%PURETEK CORPORATION07a258e4-4858-43b3-e063-6394a90a50842024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%NuCare Pharmaceuticals,Inc.1ac8a196-010f-a986-e063-6294a90a948f2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 5 % Medicated PatchPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBDfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Medicated PadSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Topical ClothSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Topical SwabSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 0.05 MG/MG Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 5 % Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchPSNfd8e4856-3785-4850-e053-6294a90a95b63
2642344Lidocan 5 % Medicated PatchPSNfd8e4856-3785-4850-e053-6294a90a95b63
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBDfd8e4856-3785-4850-e053-6294a90a95b63
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfd8e4856-3785-4850-e053-6294a90a95b63
1745091lidocaine 5 % Medicated PatchSYfd8e4856-3785-4850-e053-6294a90a95b63
2642344Lidocan 0.05 MG/MG Medicated PatchSYfd8e4856-3785-4850-e053-6294a90a95b63
2642344Lidocan 5 % Medicated PatchSYfd8e4856-3785-4850-e053-6294a90a95b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-905-545908809055430 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) 30 pouch2023-07-14NoNoCurrent
59088-905-825908809058215 POUCH in 1 PACKAGE (59088-905-82) / 1 PATCH in 1 POUCH (59088-905-84) 15 pouch2026-01-27NoNoCurrent
59088-905-84590880905841 in 1 POUCHHistorical