LIDOCAINE

Product NDC: 80175-0418
Requested package NDC: 80175-0418-5
11-digit product format: 801750418
Labeler code: 80175
Product ID: 80175-0418_be2804cd-eb5f-d5e2-e053-2a95a90a4938
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Central Packaging
Application: ANDA206498
Marketing category: ANDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
Substance: LIDOCAINE
Active strength: 50 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],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	80175-0418	80175-0418-5	I	Inactivated by FDA		2026-08-07

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 · 19 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A206498-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2016-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206498-001	AT

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	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`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	A206498-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206498-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206498-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206498-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206498-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206498-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206498-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206498-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206498-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206498-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206498-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206498-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206498-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206498-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206498-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206498-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206498-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206498-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206498-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206498-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206498-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206498-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206498-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206498-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206498-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206498-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206498-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206498-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206498-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206498-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206498-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206498-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206498-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206498-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206498-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206498-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206498-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206498-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206498-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206498-001	AT	1	`cb3db0bc1861…`

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80175-0418-5	LIDOCAINE	50 g in 1 JAR	OINTMENT	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80175-0418	LIDOCAINE OINTMENT [CENTRAL PACKAGING]	1	Legacy NDC, 1 package rows	20210303_bc92d8aa-1524-6456-e053-2995a90a1cd3.zip

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lidocaine	LIDOCAINE	REMEDYREPACK INC.	2cc3d25d-cefd-448d-beec-ac602c2110fd	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	REMEDYREPACK INC.	499b4443-7aed-4ac5-ab16-f47e759c3201	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Northstar Rx LLC	cde68b0c-a1ee-421d-9ca8-bc571d2990ab	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	54df7353-5411-43ad-bd7b-a3d4d62c72c6	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
Lidocaine	LIDOCAINE	Direct_Rx	00725e5b-694c-b9e1-e063-6294a90a4182	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	A-S Medication Solutions	967b0c5d-679d-4b69-9d6a-bc322baf6e04	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	PHOENIX RX LLC	3a602aee-09e2-892c-e063-6294a90a558f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	4134f30d-5cb0-e14b-e063-6394a90a4523	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18bae4a-11ac-7319-e053-2995a90ad1e8	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	259f7b21-98c7-3b41-e063-6294a90a34fa	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Asclemed USA, Inc.	58c9afe4-dc36-4f71-8e76-8dff63dc35fb	2023-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Proficient Rx LP	8a85ea77-91ad-4222-9bfe-2ffaf73182e8	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Proficient Rx LP	f9b290d2-0e24-4ca8-bca2-3016f5c404df	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Glenmark Pharmaceuticals Inc., USA	eaa15be7-11ea-49bc-ac07-739075453be6	2021-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Asclemed USA, Inc.	6abf3773-0e60-48b1-9d5c-adc590363d13	2021-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1543069	lidocaine 5 % Topical Ointment	PSN	bc92d8aa-1524-6456-e053-2995a90a1cd3	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	bc92d8aa-1524-6456-e053-2995a90a1cd3	1
1543069	lidocaine 5 % Topical Ointment	SY	bc92d8aa-1524-6456-e053-2995a90a1cd3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80175-0418-5	80175041805	50 g in 1 JAR (80175-0418-5)	50 g	2016-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-03-02	HUMAN PRESCRIPTION DRUG LABEL	1