Home NDC 61919-140 LIDOCAINE VISCOUS
Product NDC 61919-140
11-digit product format 619190140
Labeler code 61919
Product ID 61919-140_9c97882c-7cfb-de65-e053-2a95a90af436
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE VISCOUS
Dosage form SOLUTION
Route ORAL; TOPICAL
Labeler Direct RX
Application ANDA088802
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-140-32 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-140-32 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-140-32 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-140-32 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-140-32 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-140-32 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-140-32 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-140-32 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-140-32 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61919-140-32 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61919-140-32 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61919-140-32 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61919-140-32 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61919-140-32 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61919-140-32 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61919-140-32 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A088802-001 LIDOCAINE VISCOUS LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1985-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088802-001 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 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-140-32 LIDOCAINE VISCOUS 100 mL in 1 BOTTLE SOLUTION 100 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-140 LIDOCAINE VISCOUS SOLUTION [DIRECT RX] 3 Legacy NDC, 1 package rows 20200121_4b54a311-fe39-4ce5-b50f-4d39ef2452ec.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Viscous LIDOCAINE HYDROCHLORIDE REMEDYREPACK INC. 6f8d20d2-6a91-4a5b-bfe8-f1baada38442 2026-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802 Lidocaine Viscous LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 79b42076-359d-4258-b1d8-f40e67ac5424 2024-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 0050d05a-b8e9-c544-e063-6294a90a0243 2024-02-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802 Lidocaine Viscous LIDOCAINE HYDROCHLORIDE A-S Medication Solutions 75f2d450-aa2e-4a09-b4f7-4fcbcbf8b205 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802
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 61919-140-32 61919014032 100 mL in 1 BOTTLE (61919-140-32) 100 ml 2015-01-01 0000-00-00 No No Current