Home NDC 51672-5305 PLIAGLIS
Product NDC 51672-5305
11-digit product format 516725305
Labeler code 51672
Product ID 51672-5305_0e6c04f1-804f-4d51-bdfd-bc21a0caeeb6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine and Tetracaine
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application NDA021717
Marketing category NDA
Marketing start 2018-12-11
Marketing end 0000-00-00
Substance LIDOCAINE; TETRACAINE
Active strength 70 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-5305-2 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-5305-2 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51672-5305-2 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51672-5305-2 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51672-5305-2 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51672-5305-2 cdf11ea48f46…ba0047e9e063…
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 N021717-001 PLIAGLIS LIDOCAINE; TETRACAINE 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021717-001 10350180 2031-01-14 Drug product 2019-11-04 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 N021717-001 12558328 2031-01-14 U-4421 2026-03-04
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 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD 2006-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021717-001 PLIAGLIS 7%;7% CREAM / TOPICAL RLD, RS 2006-06-29 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 125 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021717-001 12558328 2031-01-14 U-4421 2026-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021717-001 12558328 2031-01-14 U-4421 2026-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021717-001 10751305 2031-01-14 Drug product 2020-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021717-001 10350180 2031-01-14 Drug product 2019-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021717-001 10603293 2031-01-14 Drug product 2020-04-14 79d66fd596c7…
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 PLIAGLIS LIDOCAINE AND TETRACAINE IPG PHARMACEUTICALS, INC. d854faa5-0af8-4684-b5cd-a0b8a91fb7cd 2026-03-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 021717 application number: NDA021717
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-5305-2 51672530502 1 TUBE in 1 CARTON (51672-5305-2) > 30 g in 1 TUBE 1 tube 2018-12-11 0000-00-00 No No Current