Home NDC 0362-0221 Lidocaine
Product NDC 0362-0221
11-digit product format 003620221
Labeler code 0362
Product ID 0362-0221_a87fa9a8-ad43-47dd-9509-47aa7c3a5157
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form OINTMENT
Route TOPICAL
Labeler Septodont, Inc.
Application ANDA040911
Marketing category ANDA
Marketing start 2015-05-20
Substance LIDOCAINE
Active strength 5 g/100g
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 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 A040911-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040911-001 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 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 5 g/100g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0362-0221-10 Lidocaine 50 g in 1 JAR OINTMENT 50 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0362-0221 LIDOCAINE OINTMENT [SEPTODONT, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20230708_82a4c16f-d47e-479f-8f85-7d1be6fc2318.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 · 1 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 0362-0221-10 00362022110 50 g in 1 JAR (0362-0221-10) 50 g 2015-05-20 0000-00-00 No No Current