Home NDC 80175-0008-5 lidocaine
Product NDC 80175-0008
Requested package NDC 80175-0008-5
11-digit product format 801750008
Labeler code 80175
Product ID 80175-0008_bd995ea8-a074-5cac-e053-2995a90a3ddd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lidocaine
Dosage form OINTMENT
Route TOPICAL
Labeler Central Packaging
Application ANDA205318
Marketing category ANDA
Marketing start 2017-02-27
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 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 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205318-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205318-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80175-0008-5 lidocaine 50 g in 1 JAR OINTMENT 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80175-0008 LIDOCAINE OINTMENT [CENTRAL PACKAGING] 1 Legacy NDC, 1 package rows 20210225_bc028dba-b823-0eeb-e053-2a95a90a7905.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80175-0008-5 80175000805 50 g in 1 JAR (80175-0008-5) 50 g 2017-02-27 0000-00-00 No No Current