Pliaglis

Product NDC: 73575-010
Requested package NDC: 73575-010-04
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73575-010	73575-010-04	D	Discontinued by firm		2026-09-14

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 1 · 18 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
73575-010-02	2024-12-04	These 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
73575-010-04	2024-12-04	These 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
73575-010-09	2024-12-04	These 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
73575-010-02	2022-01-28	These 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
73575-010-04	2022-01-28	These 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
73575-010-09	2022-01-28	These 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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
0619F35CGV	TETRACAINE	94-24-6	TETRACAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73575-010-04	73575001004	4 TUBE in 1 CARTON (73575-010-04) > 30 g in 1 TUBE	4 tube	2020-01-24	0000-00-00	No	No	Current