FDA.reportPublic FDA data

Lidocaine 5%

Product NDC
80175-0118
11-digit product format
801750118
Labeler code
80175
Product ID
80175-0118_be39192c-c4e4-ee5f-e053-2a95a90aacd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Central Packaging
Application
ANDA209190
Marketing category
ANDA
Marketing start
2020-05-14
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80175-0118IInactivated by FDA2026-07-31
excluded packagepackage80175-011880175-0118-3IInactivated by FDA2026-07-31

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
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
2026-08-01 22:54:322026-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209190-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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%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
Lidocaine 5%LIDOCAINE 5%A-S Medication Solutionsfec1e759-60e4-47d4-bd54-947f18b103dd2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80175-0118-3Lidocaine 5%1 in 1 PATCHPATCH11
80175-0118-3Lidocaine 5%30 in 1 PACKAGEPATCH301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0118LIDOCAINE 5% (LIDOCAINE) PATCH [CENTRAL PACKAGING]1Legacy NDC, 2 package rows20210213_bb173e93-6932-5996-e053-2a95a90a3225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSNbb173e93-6932-5996-e053-2a95a90a32251
1745091lidocaine 0.05 MG/MG Medicated PatchSCDbb173e93-6932-5996-e053-2a95a90a32251
1745091lidocaine 5 % Medicated PatchSYbb173e93-6932-5996-e053-2a95a90a32251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80175-0118-38017501180330 PATCH in 1 PACKAGE (80175-0118-3) > 1 POUCH in 1 PATCH > 1 PATCH in 1 POUCH30 patch2020-05-140000-00-00NoNoCurrent