Home Applications 212486 Application 212486
Type ANDA
Sponsor SUNGEN PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% No No
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 A212486-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17
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 2026-09-14 22:38:34 2026-08 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212486-001 LIDOCAINE 5.0% OINTMENT / TOPICAL AT 2019-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212486-001 LIDOCAINE 5.0% OINTMENT / TOPICAL AT 2019-10-17 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212486-001 LIDOCAINE 5% OINTMENT / TOPICAL 2019-10-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-12-13 00:20 UTC 2019-12 A212486-001 AT 1 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A212486-001 AT 1 3f01610625f2…
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 17 of 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 5523fdfe-69fd-49a5-b51f-73e2223d49a9 2025-05-01 Warnings, Adverse reactions Name fallback brand name: Lidocaine Maximum Strength 4% Lidocaine Patch LIDOCAINE Solis Pharmaceuticals Inc. 3061d301-2104-b1b2-e063-6394a90a9b6e 2025-04-29 Warnings Name fallback generic name: LIDOCAINE Maximum Strength 4% Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 33ed754e-8852-d5b2-e063-6394a90a7cf2 2025-04-29 Warnings Name fallback generic name: LIDOCAINE Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 32b96689-8e9b-4c2e-e063-6294a90a7d1c 2025-04-29 Warnings Name fallback generic name: LIDOCAINE Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Name fallback generic name: LIDOCAINE Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Name fallback generic name: LIDOCAINE Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Name fallback generic name: LIDOCAINE Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 Warnings Name fallback generic name: LIDOCAINE Walgreens Lidocaine Back LIDOCAINE Walgreen Co. e6bfd342-c0db-46b9-b5e6-5acbd860adf1 2025-04-25 Warnings Name fallback generic name: LIDOCAINE Maximum Strength 4% Lidocaine Patch LIDOCAINE Pharmheal 32e57c0f-d138-88dc-e063-6394a90ac085 2025-04-16 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Advanced Rx of Tennessee, LLC 325ddb61-84f5-075c-e063-6294a90ad5e9 2025-04-10 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Numb 520 LIDOCAINE Clinical Resolution Laboratory, Inc. 984c4bee-0d44-4e0f-a057-0d54400c4cac 2025-04-02 Warnings Name fallback generic name: LIDOCAINE HemAway LIDOCAINE Melaleuca, Inc. cf842adf-fcd7-2c8c-e053-2995a90adea6 2025-03-27 Warnings Name fallback generic name: LIDOCAINE Numb and Number Anorectal Cream LIDOCAINE Dermtech Labs, Inc 31420635-5021-173d-e063-6294a90a407a 2025-03-26 Warnings Name fallback generic name: LIDOCAINE Adellina Numbing Cream LIDOCAINE Guangzhou Haishi Biological Technology Co., Ltd. 314a83fe-8bdb-766f-e063-6294a90a61c6 2025-03-26 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC cddb2b22-fce3-8967-6e54-dca3df5ac4b3 2025-03-26 Warnings, Adverse reactions Name fallback brand name: Lidocaine Leader Maximum Strength Hemorrhoidal Relief LIDOCAINE Cardinal Health,Inc. 65c780b0-7f47-4ae9-a847-c22deaaa2888 2025-03-21 Warnings Name fallback generic name: LIDOCAINE Lidocaine 4% LIDOCAINE Innovida Pharmaeutique Corporation eb83a3dd-557e-4334-b806-5fc05e9175a3 2025-03-19 Warnings Name fallback generic name: LIDOCAINE TheraCare Pain Relief 4% Lidocaine LIDOCAINE Veridian Healthcare 2d3fc030-5d53-2acd-e063-6294a90a11ab 2025-03-11 Warnings Name fallback generic name: LIDOCAINE Muscle and Joint Care LIDOCAINE Vege Labs LLC. 301966b5-b535-dc04-e063-6394a90aec17 2025-03-11 Warnings Name fallback generic name: LIDOCAINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70625-400 Lidocaine Lidocaine SunGen Pharma LLC ANDA Current 71329-401 Lidocaine Lidocaine GeneYork Pharmaceuticals Group LLC ANDA Current