Pliaglis

Product NDC
73575-010
11-digit product format
735750010
Labeler code
73575
Product ID
73575-010_92f4411a-9390-41b3-a643-6626d8c6cb48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and tetracaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Oba Pharmaceuticals, Inc.
Application
NDA021717
Marketing category
NDA
Marketing start
2020-01-24
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73575-010DDiscontinued by firm2026-09-14
excluded packagepackage73575-01073575-010-02DDiscontinued by firm2026-09-14
excluded packagepackage73575-01073575-010-04DDiscontinued by firm2026-09-14
excluded packagepackage73575-01073575-010-09DDiscontinued by firm2026-09-14

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 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73575-010-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73575-010-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73575-010-09DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73575-010-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73575-010-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73575-010-09DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73575-010-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73575-010-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73575-010-09DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73575-010-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73575-010-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73575-010-09DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73575-010-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73575-010-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73575-010-09DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73575-010-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73575-010-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73575-010-09DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73575-010-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73575-010-04DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73575-010-09DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73575-010-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73575-010-04DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73575-010-09DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73575-010-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73575-010-04DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73575-010-09DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73575-010-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73575-010-09IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73575-010-04IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73575-010-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73575-010-09IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73575-010-04IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73575-010-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73575-010-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73575-010-04IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73575-010-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73575-010-09IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage73575-010-04IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73575-010-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73575-010-09IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage73575-010-04IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73575-010-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73575-010-09IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage73575-010-04IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021717-001PLIAGLISLIDOCAINE; TETRACAINE7%;7%CREAM / TOPICALRLD, RS2006-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021717-001103501802031-01-14Drug product2019-11-04
N021717-001106032932031-01-14Drug product2020-04-14
N021717-001107513052031-01-14Drug product2020-09-21
N021717-001125583282031-01-14U-44212026-03-04

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-2984e616aacf4f…
2026-08-18 06:07:402026-07N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD2006-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021717-001PLIAGLIS7%;7%CREAM / TOPICALRLD, RS2006-06-29f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N021717-001103501802031-01-14Drug product2019-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N021717-001106032932031-01-14Drug product2020-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N021717-001107513052031-01-14Drug product2020-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N021717-001125583282031-01-14U-44212026-03-0484e616aacf4f…
2026-08-18 06:07:402026-07N021717-001103501802031-01-14Drug product2019-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N021717-001106032932031-01-14Drug product2020-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021717-001107513052031-01-14Drug product2020-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021717-001125583282031-01-14U-44212026-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021717-001103501802031-01-14Drug product2019-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021717-001106032932031-01-14Drug product2020-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021717-001107513052031-01-14Drug product2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021717-001103501802031-01-14Drug product2019-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021717-001106032932031-01-14Drug product2020-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021717-001107513052031-01-14Drug product2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021717-001103501802031-01-14Drug product2019-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021717-001106032932031-01-14Drug product2020-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021717-001107513052031-01-14Drug product2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021717-001103501802031-01-14Drug product2019-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021717-001106032932031-01-14Drug product2020-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021717-001107513052031-01-14Drug product2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021717-001103501802031-01-14Drug product2019-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021717-001106032932031-01-14Drug product2020-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021717-001107513052031-01-14Drug product2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021717-001103501802031-01-14Drug product2019-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021717-001106032932031-01-14Drug product2020-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021717-001107513052031-01-14Drug product2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021717-001103501802031-01-14Drug product2019-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021717-001106032932031-01-14Drug product2020-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021717-001107513052031-01-14Drug product2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021717-001103501802031-01-14Drug product2019-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021717-001106032932031-01-14Drug product2020-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021717-001107513052031-01-14Drug product2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021717-001103501802031-01-14Drug product2019-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021717-001106032932031-01-14Drug product2020-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021717-001107513052031-01-14Drug product2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021717-001103501802031-01-14Drug product2019-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N021717-001106032932031-01-14Drug product2020-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021717-001107513052031-01-14Drug product2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021717-001103501802031-01-14Drug product2019-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021717-001106032932031-01-14Drug product2020-04-1479d66fd596c7…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
73575-010-022024-12-04These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS ® (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006
73575-010-042024-12-04These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS ® (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006
73575-010-092024-12-04These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS ® (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006
73575-010-022022-01-28These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS ® (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006
73575-010-042022-01-28These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS ® (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006
73575-010-092022-01-28These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS ® (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PLIAGLISLIDOCAINE AND TETRACAINEIPG PHARMACEUTICALS, INC.d854faa5-0af8-4684-b5cd-a0b8a91fb7cd2026-03-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 021717
application number: NDA021717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73575-010-02735750010022 TUBE in 1 CARTON (73575-010-02) > 30 g in 1 TUBE2 tube2020-01-240000-00-00NoNoCurrent
73575-010-04735750010044 TUBE in 1 CARTON (73575-010-04) > 30 g in 1 TUBE4 tube2020-01-240000-00-00NoNoCurrent
73575-010-09735750010091 TUBE in 1 CARTON (73575-010-09) > 30 g in 1 TUBE1 tube2020-01-240000-00-00NoNoCurrent