Lidocaine

Product NDC
50436-0473
11-digit product format
504360473
Labeler code
50436
Product ID
50436-0473_dc462017-0054-4d05-b607-93805601edd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA207810
Marketing category
ANDA
Marketing start
2017-03-10
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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-0473IInactivated by FDA2026-08-11
excluded packagepackage50436-047350436-0473-1IInactivated by FDA2026-08-11
excluded packagepackage50436-047350436-0473-2IInactivated by FDA2026-08-11

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-0473-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-0473-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-0473-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-0473-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-0473-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-0473-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-0473-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-0473-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-0473-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-0473-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-0473-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-0473-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0473-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0473-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0473-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0473-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0473-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0473-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0473-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0473-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0473-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0473-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0473-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0473-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0473-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0473-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0473-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0473-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0473-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0473-21332a3947898…d4bfe170f9cd…

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
A207810-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2017-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207810-001AT

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 UTC2026-02A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-103f01610625f2…
2019-09-15 20:21 UTC2019-09A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207810-001LIDOCAINE5%OINTMENT / TOPICALAT2017-03-10cb3db0bc1861…

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 UTC2026-02A207810-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207810-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207810-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207810-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207810-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207810-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207810-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207810-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207810-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207810-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207810-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207810-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207810-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207810-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207810-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207810-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207810-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207810-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207810-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207810-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207810-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A207810-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207810-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207810-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207810-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A207810-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207810-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207810-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207810-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207810-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207810-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207810-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207810-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207810-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207810-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207810-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207810-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207810-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207810-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207810-001AT1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0473-1Lidocaine50 g in 1 TUBEOINTMENT504
50436-0473-1Lidocaine1 in 1 CARTONOINTMENT14
50436-0473-2Lidocaine1 in 1 CARTONOINTMENT14
50436-0473-2Lidocaine35.44 g in 1 TUBEOINTMENT35.444

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0473-1GM - Gram50436-0473a5985931-322c-409d-bd44-914e3710a49412021-10-08
50436-0473-2GM - Gram50436-0473b7001bd3-9532-40be-b3f2-239873226b7912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0473LIDOCAINE OINTMENT [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20220612_abf864dd-e75f-4a02-8caf-3ad816cd540b.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINELIDOCAINEDIRECT RXb8663046-67a4-4858-e053-2a95a90a8aed2026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207810
application number: ANDA207810
LidocaineLIDOCAINEBryant Ranch Prepacka134c265-4fb6-4c78-b9cc-fae8f1fff1cf2023-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207810
application number: ANDA207810
LidocaineLIDOCAINEBryant Ranch Prepack68bc320f-2871-45b9-815e-bb26081e82492023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207810
application number: ANDA207810
LidocaineLIDOCAINEBryant Ranch Prepackda9707e2-f830-45e2-a300-1f99cf3dd3622023-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207810
application number: ANDA207810
LidocaineLIDOCAINEProficient Rx LP2c396307-cf12-41d0-89e6-0f4ec74df55e2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207810
application number: ANDA207810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNabf864dd-e75f-4a02-8caf-3ad816cd540b4
1543069lidocaine 0.05 MG/MG Topical OintmentSCDabf864dd-e75f-4a02-8caf-3ad816cd540b4
1543069lidocaine 5 % Topical OintmentSYabf864dd-e75f-4a02-8caf-3ad816cd540b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0473-1504360473011 TUBE in 1 CARTON (50436-0473-1) > 50 g in 1 TUBE1 tube2021-08-240000-00-00NoNoCurrent
50436-0473-2504360473021 TUBE in 1 CARTON (50436-0473-2) > 35.44 g in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent