Home NDC 69557-111 Ztlido
Product NDC 69557-111
11-digit product format 695570111
Labeler code 69557
Product ID 69557-111_25e03ec1-e3a9-2483-e063-6394a90ad2d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form PATCH
Route TOPICAL
Labeler Scilex Pharmaceuticals Inc.
Application NDA207962
Marketing category NDA
Marketing start 2018-04-26
Substance LIDOCAINE
Active strength 36 mg/1
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 N207962-001 ZTLIDO LIDOCAINE 1.8% PATCH / TOPICAL AB RLD, RS 2018-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207962-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207962-001 10765640 2031-05-10 Drug product 2020-10-06 N207962-001 10765749 2031-05-10 Drug product 2020-10-06 N207962-001 11278623 2031-05-10 Drug product 2022-04-01 N207962-001 11786455 2031-05-10 U-2267 Drug product 2023-10-23 N207962-001 11793766 2031-05-10 U-2267 2023-11-06 N207962-001 9283174 2031-05-10 Drug product 2018-03-12 N207962-001 9925264 2031-05-10 U-2267 Drug product 2018-04-25 N207962-001 9931403 2031-05-10 Drug product 2018-04-25
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 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL AB RLD, RS 2018-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL AB RLD, RS 2018-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL AB RLD, RS 2018-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207962-001 ZTLIDO 1.8% PATCH / TOPICAL RLD, RS 2018-02-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207962-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207962-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N207962-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 265 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207962-001 10765640 2031-05-10 Drug product 2020-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 10765749 2031-05-10 Drug product 2020-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 11278623 2031-05-10 Drug product 2022-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 11786455 2031-05-10 U-2267 Drug product 2023-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 11793766 2031-05-10 U-2267 2023-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 9283174 2031-05-10 Drug product 2018-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 9925264 2031-05-10 U-2267 Drug product 2018-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207962-001 9931403 2031-05-10 Drug product 2018-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 10765640 2031-05-10 Drug product 2020-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 10765749 2031-05-10 Drug product 2020-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 11278623 2031-05-10 Drug product 2022-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 11786455 2031-05-10 U-2267 Drug product 2023-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 11793766 2031-05-10 U-2267 2023-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 9283174 2031-05-10 Drug product 2018-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 9925264 2031-05-10 U-2267 Drug product 2018-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207962-001 9931403 2031-05-10 Drug product 2018-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207962-001 10765640 2031-05-10 Drug product 2020-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 10765749 2031-05-10 Drug product 2020-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 11278623 2031-05-10 Drug product 2022-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 11786455 2031-05-10 U-2267 Drug product 2023-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 11793766 2031-05-10 U-2267 2023-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 9283174 2031-05-10 Drug product 2018-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 9925264 2031-05-10 U-2267 Drug product 2018-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207962-001 9931403 2031-05-10 Drug product 2018-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 10765640 2031-05-10 Drug product 2020-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 10765749 2031-05-10 Drug product 2020-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 11278623 2031-05-10 Drug product 2022-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 11786455 2031-05-10 U-2267 Drug product 2023-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 11793766 2031-05-10 U-2267 2023-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 9283174 2031-05-10 Drug product 2018-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 9925264 2031-05-10 U-2267 Drug product 2018-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207962-001 9931403 2031-05-10 Drug product 2018-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 10765640 2031-05-10 Drug product 2020-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 10765749 2031-05-10 Drug product 2020-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 11278623 2031-05-10 Drug product 2022-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 11786455 2031-05-10 U-2267 Drug product 2023-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 11793766 2031-05-10 U-2267 2023-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 9283174 2031-05-10 Drug product 2018-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 9925264 2031-05-10 U-2267 Drug product 2018-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207962-001 9931403 2031-05-10 Drug product 2018-04-25 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Ztlido
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 36 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2001434 Internal RxNorm lookup 2001439 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69557-111 ZTLIDO (LIDOCAINE) PATCH [SCILEX PHARMACEUTICALS INC.] 26 Current NDC, Legacy NDC, 4 package rows 20241105_a1b17507-4560-490d-a388-74e7fd7eaa5e.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 69557-111-01 69557011101 1 in 1 POUCH Historical 69557-111-03 69557011103 3 POUCH in 1 CARTON (69557-111-03) / 1 PATCH in 1 POUCH 3 pouch 2018-04-26 0000-00-00 Yes No Current 69557-111-30 69557011130 30 POUCH in 1 CARTON (69557-111-30) / 1 PATCH in 1 POUCH (69557-111-01) 30 pouch 2018-04-26 0000-00-00 No No Current