Lidocaine

Product NDC
67877-473
Requested package NDC
67877-473-80
11-digit product format
678770473
Labeler code
67877
Product ID
67877-473_3edb9bb8-2e70-4ee3-bf41-90c53c4d5920
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Ascend Laboratories, LLC
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67877-47367877-473-80IInactivated 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 · 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

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…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-473-79Lidocaine35.44 g in 1 TUBEOINTMENT35.4411
67877-473-79Lidocaine1 in 1 CARTONOINTMENT111
67877-473-80Lidocaine1 in 1 CARTONOINTMENT111
67877-473-80Lidocaine50 g in 1 TUBEOINTMENT5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-473-79GM - Gram67877-473e617c21c-f794-43d0-b63c-fcae10a0a8b912017-05-04
67877-473-80GM - Gram67877-47372c2f0b3-a14c-431b-883f-993b7be93a3412017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-473LIDOCAINE OINTMENT [ASCEND LABORATORIES, LLC]11Legacy NDC, 4 package rows20220920_e2748dfb-bffe-47a8-a886-853d0f7c910a.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 OintmentPSNa134c265-4fb6-4c78-b9cc-fae8f1fff1cf103
1543069lidocaine 0.05 MG/MG Topical OintmentSCDa134c265-4fb6-4c78-b9cc-fae8f1fff1cf103
1543069lidocaine 5 % Topical OintmentSYa134c265-4fb6-4c78-b9cc-fae8f1fff1cf103
1543069lidocaine 5 % Topical OintmentPSN68bc320f-2871-45b9-815e-bb26081e8249102
1543069lidocaine 5 % Topical OintmentPSNda9707e2-f830-45e2-a300-1f99cf3dd362102
1543069lidocaine 0.05 MG/MG Topical OintmentSCD68bc320f-2871-45b9-815e-bb26081e8249102
1543069lidocaine 0.05 MG/MG Topical OintmentSCDda9707e2-f830-45e2-a300-1f99cf3dd362102
1543069lidocaine 5 % Topical OintmentSY68bc320f-2871-45b9-815e-bb26081e8249102
1543069lidocaine 5 % Topical OintmentSYda9707e2-f830-45e2-a300-1f99cf3dd362102
1543069lidocaine 5 % Topical OintmentPSNe2748dfb-bffe-47a8-a886-853d0f7c910a11
1543069lidocaine 0.05 MG/MG Topical OintmentSCDe2748dfb-bffe-47a8-a886-853d0f7c910a11
1543069lidocaine 5 % Topical OintmentSYe2748dfb-bffe-47a8-a886-853d0f7c910a11
1543069lidocaine 5 % Topical OintmentPSNb8663046-67a4-4858-e053-2a95a90a8aed7
1543069lidocaine 0.05 MG/MG Topical OintmentSCDb8663046-67a4-4858-e053-2a95a90a8aed7
1543069lidocaine 5 % Topical OintmentSYb8663046-67a4-4858-e053-2a95a90a8aed7
1543069lidocaine 5 % Topical OintmentPSN2c396307-cf12-41d0-89e6-0f4ec74df55e5
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2c396307-cf12-41d0-89e6-0f4ec74df55e5
1543069lidocaine 5 % Topical OintmentSY2c396307-cf12-41d0-89e6-0f4ec74df55e5
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
1543069lidocaine 5 % Topical OintmentPSN7e81c577-5a08-4c97-93e1-7a05c2f7c2372
1543069lidocaine 0.05 MG/MG Topical OintmentSCD7e81c577-5a08-4c97-93e1-7a05c2f7c2372
1543069lidocaine 5 % Topical OintmentSY7e81c577-5a08-4c97-93e1-7a05c2f7c2372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-473-80678770473801 TUBE in 1 CARTON (67877-473-80) > 50 g in 1 TUBE1 tube2017-03-100000-00-00NoNoCurrent