Lidocaine

Product NDC
69336-103
11-digit product format
693360103
Labeler code
69336
Product ID
69336-103_bedefd71-0163-4153-e053-2995a90a77fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sterling-Knight Pharmaceuticals, LLC
Application
ANDA206297
Marketing category
ANDA
Marketing start
2016-08-15
Marketing end
0000-00-00
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
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69336-103DDiscontinued by firm2026-08-17
excluded packagepackage69336-10369336-103-35DDiscontinued by firm2026-08-17

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69336-103-35DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69336-103-35DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69336-103-35DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69336-103-35DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69336-103-35DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69336-103-35DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69336-103-35DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69336-103-35DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69336-103-35DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69336-103-35DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69336-103-35DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69336-103-35DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69336-103-35IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69336-103-35IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206297-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206297-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206297-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206297-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206297-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206297-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206297-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206297-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206297-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206297-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206297-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206297-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206297-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206297-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206297-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206297-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206297-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206297-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206297-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206297-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206297-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206297-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206297-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206297-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A206297-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206297-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206297-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206297-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206297-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206297-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206297-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206297-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206297-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206297-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206297-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206297-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206297-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206297-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206297-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206297-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206297-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206297-001AT1e64feba35796…

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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-103-35GM - Gram69336-10322358797-740c-4c10-9e82-cfde9de02aa512016-09-02

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEPreferred Pharmaceuticals Inc.4806f94d-cbac-4107-b93b-8f715868ffb32026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEPHOENIX RX LLC40949067-a5a8-db8c-e063-6294a90af0fb2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf18b8413-8f52-a927-e053-2a95a90a402a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf93cbde5-329a-f880-e053-6294a90a1af22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEBryant Ranch Prepack6fe7721d-42b3-4284-936b-a448ca530c452023-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAmneal Pharmaceuticals LLCd1509740-f9f1-44e3-8fde-51d8683fcd872018-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN930f1974-c050-404f-b720-72befdd6e3b95
1543069lidocaine 0.05 MG/MG Topical OintmentSCD930f1974-c050-404f-b720-72befdd6e3b95
1543069lidocaine 5 % Topical OintmentSY930f1974-c050-404f-b720-72befdd6e3b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69336-103-35693360103351 TUBE in 1 CARTON (69336-103-35) > 35.44 g in 1 TUBE1 tube2016-08-150000-00-00NoNoCurrent