Home NDC 72189-493-35 Lidocaine
Product NDC 72189-493
Requested package NDC 72189-493-35
11-digit product format 721890493
Labeler code 72189
Product ID 72189-493_2c4e3760-8447-4adb-e063-6394a90a5ffc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form OINTMENT
Route TOPICAL
Labeler Direct_Rx
Application ANDA210958
Marketing category ANDA
Marketing start 2023-06-22
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 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-493 72189-493-35 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-493 72189-493-35 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210958-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210958-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210958-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2018-12-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1543069 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-493-35 Lidocaine 35.44 g in 1 TUBE OINTMENT 35.44 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-493 LIDOCAINE OINTMENT [DIRECT_RX] 2 Current NDC, 1 package rows 20250123_feb8692a-9c08-0d5c-e053-6394a90a904b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72189-493-35 72189049335 35.44 g in 1 TUBE (72189-493-35) 35.44 g 2023-06-22 No No Current