Lidocaine and Prilocaine

Product NDC: 0115-1468
11-digit product format: 001151468
Labeler code: 0115
Product ID: 0115-1468_ef0e52f0-eafb-4ccc-86f4-19672a142b3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA076320
Marketing category: ANDA
Marketing start: 2003-08-27
Marketing end: 0000-00-00
Substance: LIDOCAINE; PRILOCAINE
Active strength: 25 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0115-1468		D	Discontinued by firm	2026-08-03
excluded package	package	0115-1468	0115-1468-45	D	Discontinued by firm	2026-08-03
excluded package	package	0115-1468	0115-1468-53	D	Discontinued by firm	2026-08-03
excluded package	package	0115-1468	0115-1468-60	D	Discontinued by firm	2026-08-03

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 · 48 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	0115-1468-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1468-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1468-45	`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	0115-1468-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-1468-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-1468-45	`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	0115-1468-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-1468-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-1468-45	`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	0115-1468-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-1468-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-1468-45	`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	0115-1468-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-1468-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-1468-45	`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	0115-1468-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-1468-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-1468-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1468-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1468-53	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1468-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1468-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1468-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1468-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1468-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1468-53	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1468-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1468-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1468-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1468-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1468-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1468-53	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1468-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1468-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1468-53	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1468-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076320-001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB		2003-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076320-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076320-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2003-08-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076320-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076320-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076320-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076320-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076320-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076320-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076320-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076320-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076320-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076320-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076320-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076320-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076320-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076320-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076320-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076320-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076320-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076320-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076320-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076320-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076320-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076320-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076320-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076320-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076320-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076320-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076320-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076320-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076320-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076320-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076320-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076320-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076320-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076320-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076320-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076320-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076320-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076320-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076320-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076320-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1468-45	GM - Gram	0115-1468	616e3ae1-bfc3-40ca-813c-25f978e7df59	1	2013-02-13
0115-1468-53	GM - Gram	0115-1468	da587c08-1370-4dad-b027-f658d5a23a72	1	2015-05-05
0115-1468-60	GM - Gram	0115-1468	6a82e2c3-f9fc-4756-b2f3-12ddb220108a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
PRILOCAINE	ACTIVE INGREDIENT	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
PRILOCAINE	ACTIVE MOIETY	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
POLYOXYL 60 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	02NG325BQG	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1

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 AND PRILOCAINE LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Encube Ethicals, Inc.	a65a29ca-9476-4290-9384-67df4caec655	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076320 application number: ANDA076320

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
046O35D44R	PRILOCAINE	721-50-6	PRILOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	PSN	004da013-8bd9-497a-b38e-14ff86859be7	5
197877	lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream	SCD	004da013-8bd9-497a-b38e-14ff86859be7	5
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	SY	004da013-8bd9-497a-b38e-14ff86859be7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1468-45	00115146845	1 TUBE in 1 CARTON (0115-1468-45) > 30 g in 1 TUBE	1 tube	2003-08-27	0000-00-00	No	No	Current
0115-1468-53	00115146853	1 TUBE in 1 CARTON (0115-1468-53) > 5 g in 1 TUBE	1 tube	2003-08-27	0000-00-00	No	No	Current
0115-1468-60	00115146860	5 TUBE in 1 CARTON (0115-1468-60) > 5 g in 1 TUBE	5 tube	2003-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine and Prilocaine Cream USP, 2.5%/2.5%	Amneal Pharmaceuticals of New York LLC	2019-04-01	HUMAN PRESCRIPTION DRUG LABEL	6
Lidocaine and Prilocaine Cream USP, 2.5%/2.5%	A-S Medication Solutions	2018-04-18	HUMAN PRESCRIPTION DRUG LABEL	5