Lidocaine and Prilocaine

Product NDC: 63739-054
Requested package NDC: 63739-054-66
11-digit product format: 637390054
Labeler code: 63739
Product ID: 63739-054_9b924815-f957-45d0-b4b4-44a8c41aa7b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: McKesson Corporation
Application: ANDA205887
Marketing category: ANDA
Marketing start: 2018-06-29
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: 2022-12-31
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	63739-054	63739-054-66	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A205887-001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL			2018-06-29

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	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205887-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2018-06-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205887-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205887-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205887-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205887-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205887-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205887-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205887-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205887-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205887-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205887-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205887-001	AB	1	`301d65b070ca…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205887-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205887-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205887-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205887-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205887-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205887-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205887-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205887-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205887-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205887-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205887-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205887-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205887-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A205887-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205887-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205887-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205887-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205887-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205887-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-054-66	2023-03-24	C162847	48780-1	f386c649-b966-0266-e053-dadaa90a7c1a	Lidocaine and Prilocaine Cream USP, 2.5%/2.5%
63739-054-66	2023-01-30	C162847	48780-1	f386c649-b966-0266-e053-dadaa90a7c1a	Lidocaine and Prilocaine Cream USP, 2.5%/2.5%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-054-66	GM - Gram	63739-054	8b7da492-2db9-4313-92d9-1b1712f389bf	1	2021-08-05

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	PAI Holdings, LLC dba PAI Pharma	58204dfe-f18d-41c4-80e4-eae54fe8d583	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205887 application number: ANDA205887

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-054-66	63739005466	1 TUBE in 1 CARTON (63739-054-66) > 30 g in 1 TUBE	1 tube	2021-05-24	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%	McKesson Corporation \| Teligent, Inc.	2023-03-24	HUMAN PRESCRIPTION DRUG LABEL	2