Lidocaine

Product NDC
17478-840
Requested package NDC
17478-840-30
11-digit product format
174780840
Labeler code
17478
Product ID
17478-840_88a310c7-1020-41de-9815-fab3035e6e17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
Akorn, Inc.
Application
ANDA040433
Marketing category
ANDA
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17478-84017478-840-30DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A040433-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040433-001AT

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 UTC2026-02A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-123f01610625f2…
2019-09-15 20:21 UTC2019-09A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALAT2003-02-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040433-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATRS2003-02-12cb3db0bc1861…

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 UTC2026-02A040433-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040433-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040433-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040433-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040433-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040433-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040433-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040433-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040433-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040433-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040433-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040433-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040433-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040433-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040433-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040433-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040433-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040433-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040433-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040433-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040433-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040433-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040433-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040433-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040433-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040433-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040433-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040433-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040433-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040433-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040433-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040433-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040433-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040433-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040433-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040433-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040433-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040433-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040433-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040433-001AT1cb3db0bc1861…

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
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-840-05ML - Milliliter17478-840ac09e4d9-50a9-40b9-b1af-0c56fe8d36df12014-02-04
17478-840-30ML - Milliliter17478-840f28ac6d1-6ebc-4e06-b769-23df196c068d12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
LidocaineACTIVE MOIETY98PI200987LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-840SX1 MEDICATED POST-OPERATIVE SYSTEM (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Legacy NDC20220302_906c715a-c47c-47f7-9ba0-4e990fb82e89.zip
17478-840VENIPUNCTURE PX1 (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Legacy NDC20220302_a76e1cee-f89e-481e-adcc-0a4e3414a8be.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDEARMAS PHARMACEUTICALS INC.2f6e0f3d-ceaf-a853-e063-6394a90a8efb2025-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040433
application number: ANDA040433

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN906c715a-c47c-47f7-9ba0-4e990fb82e894
797544isopropyl alcohol 70 % Medicated PadPSNa76e1cee-f89e-481e-adcc-0a4e3414a8be4
1011852lidocaine HCl 2 % Topical GelPSN906c715a-c47c-47f7-9ba0-4e990fb82e894
1011852lidocaine HCl 2 % Topical GelPSNa76e1cee-f89e-481e-adcc-0a4e3414a8be4
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD906c715a-c47c-47f7-9ba0-4e990fb82e894
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa76e1cee-f89e-481e-adcc-0a4e3414a8be4
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD906c715a-c47c-47f7-9ba0-4e990fb82e894
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDa76e1cee-f89e-481e-adcc-0a4e3414a8be4
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY906c715a-c47c-47f7-9ba0-4e990fb82e894
797544isopropyl alcohol 70 % Medicated PadSYa76e1cee-f89e-481e-adcc-0a4e3414a8be4
797544isopropyl alcohol 70 % Topical ClothSYa76e1cee-f89e-481e-adcc-0a4e3414a8be4
797544isopropyl alcohol 70 % Topical SwabSYa76e1cee-f89e-481e-adcc-0a4e3414a8be4
1011852lidocaine hydrochloride 2 % Topical JellySY906c715a-c47c-47f7-9ba0-4e990fb82e894
1011852lidocaine hydrochloride 2 % Topical JellySYa76e1cee-f89e-481e-adcc-0a4e3414a8be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-840-30174780840301 TUBE, WITH APPLICATOR in 1 CARTON (17478-840-30) > 30 mL in 1 TUBE, WITH APPLICATOR2013-08-010000-00-00NoNoCurrent