PLIAGLIS

Product NDC: 71085-100
11-digit product format: 710850100
Labeler code: 71085
Product ID: 71085-100_4c97e0ed-1d3a-44af-e063-6294a90ae75f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Tetracaine
Dosage form: CREAM
Route: TOPICAL
Labeler: IPG PHARMACEUTICALS, INC.
Application: NDA021717
Marketing category: NDA
Marketing start: 2026-03-06
Substance: LIDOCAINE; TETRACAINE
Active strength: 70; 70 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: PLIAGLIS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	70 mg/g
TETRACAINE	70 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup
0619F35CGV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
687443	Internal RxNorm lookup
728126	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71085-100-30	PLIAGLIS	1 in 1 CARTON	CREAM	1		1
71085-100-30	PLIAGLIS	30 g in 1 TUBE	CREAM	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71085-100-30	GM - Gram	71085-100	298b48ae-701c-4550-bf6b-733b3940ba6a	1	2026-04-20

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 ndc (product): 71085-100

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
687443	lidocaine 7 % / tetracaine 7 % Topical Cream	PSN	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	1
728126	Pliaglis 7 % / 7 % Topical Cream	PSN	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	1
728126	lidocaine 70 MG/ML / tetracaine 70 MG/ML Topical Cream [Pliaglis]	SBD	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	1
687443	lidocaine 70 MG/ML / tetracaine 70 MG/ML Topical Cream	SCD	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	1
687443	lidocaine 7 % / tetracaine 7 % Topical Cream	SY	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	1
728126	Pliaglis (lidocaine 7 % / tetracaine 7 % ) Topical Cream	SY	d854faa5-0af8-4684-b5cd-a0b8a91fb7cd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71085-100-30	71085010030	1 TUBE in 1 CARTON (71085-100-30) / 30 g in 1 TUBE	1 tube	2026-03-06	No	No	Current