Home NDC 17478-711-30 Lidocaine
Product NDC 17478-711
Requested package NDC 17478-711-30
11-digit product format 174780711
Labeler code 17478
Product ID 17478-711_cabfb396-7b14-40b5-a647-634e907e2d3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form JELLY
Route TOPICAL
Labeler Akorn
Application ANDA040433
Marketing category ANDA
Marketing start 2003-08-01
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 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A040433-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040433-001 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 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Lidocaine Hydrochloride ACTIVE INGREDIENT V13007Z41A LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 Lidocaine Hydrochloride ACTIVE INGREDIENT V13007Z41A LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1 Lidocaine ACTIVE MOIETY 98PI200987 LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 Lidocaine ACTIVE MOIETY 98PI200987 LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-711 LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN] 8 Legacy NDC, 6 package rows 20220914_317a8784-5fdd-429f-9b74-14d89f372a32.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE HYDROCHLORIDE ARMAS PHARMACEUTICALS INC. 2f6e0f3d-ceaf-a853-e063-6394a90a8efb 2025-03-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040433 application number: ANDA040433
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17478-711-30 17478071130 1 TUBE, WITH APPLICATOR in 1 CARTON (17478-711-30) > 30 mL in 1 TUBE, WITH APPLICATOR 2003-08-01 0000-00-00 No No Current