Home Applications 040837 Application 040837
Type ANDA
Sponsor WATSON LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE JELLY;TOPICAL 2% 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 A040837-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23
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 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 f41ea6bd6efb…
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 5 of 16 · 304 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC 0a1aeff0-bade-457b-a0ac-099d646c0b2e 2026-01-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE 2.0% LIDOCAINE BURN LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC e1911279-85f7-4053-b6da-8f4e991347a2 2026-01-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Precision Dose, Inc. 27b6ef54-a093-2bef-e063-6394a90a7912 2025-12-29 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE WALGREENS BURN LIDOCAINE HYDROCHLORIDE WALGREENS b61e6d73-4f41-ef50-e053-2a95a90a0fc6 2025-12-29 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme with Lidocaine Foot Pain Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. da82cc0e-cc39-408e-87e1-c35bb6f9f51e 2025-12-19 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 38560997-cfe4-2f9b-e063-6394a90a834b 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 3f2c33e5-290e-2f89-e063-6394a90aee69 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 42caf92e-6fa9-5bd7-e063-6294a90a3904 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 42d9e4cf-ca73-ec6d-e063-6394a90ae937 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 3f2bdb1f-f1c0-370d-e063-6294a90a5c50 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 4643042c-ec95-3bad-e063-6294a90a8250 2025-12-18 Warnings, Adverse reactions Name fallback brand name: lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cardinal Health 107, LLC 4e46cac7-00cd-4a01-ba11-9af4960cfbe9 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Gold Bond Medicated Pain and Itch Relief LIDOCAINE HYDROCHLORIDE Gold Bond Co LLC d240e9b8-3506-42ab-8a50-05e8d3fac4ff 2025-12-04 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE POMG NIGHT TIME PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE POMG LLC 28d7dfb0-a94c-90de-e063-6294a90a036a 2025-12-02 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Brookfield Pharmaceuticals, LLC. e824ba5b-3289-5ad4-e053-2995a90acc20 2025-11-27 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Walgreen Pain Relieving Fragrance Free LIDOCAINE HYDROCHLORIDE WALGREENS CO. 62c50ded-3fc9-4f65-9bfb-1144ed2e36b4 2025-11-26 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE A-S Medication Solutions 82b377ee-0e3e-4cb9-a644-f45434c21cca 2025-11-26 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 42df73b0-20ee-d1aa-e063-6294a90aa275 2025-11-21 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Dextrum Laboratories, Inc 441daa6f-f273-ac09-e063-6394a90a252c 2025-11-21 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. 313a7e1f-c1a9-4fa5-bb83-7256c271b351 2025-11-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-3012 Lidocaine Lidocaine Hydrochloride Actavis Pharma, Inc. ANDA Current 53217-222 Lidocaine Lidocaine Hydrochloride Aidarex Pharmaceuticals LLC ANDA Current 53217-223 Lidocaine Lidocaine Hydrochloride Aidarex Pharmaceuticals LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42638 ORIG 2013-10-23