Lidocaine

Product NDC: 80425-0324
Requested package NDC: 80425-0324-1
11-digit product format: 804250324
Labeler code: 80425
Product ID: 80425-0324_2a9bf7d3-46dc-0dfa-e063-6394a90a76a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA206297
Marketing category: ANDA
Marketing start: 2023-04-13
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: 2026-12-31
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
A206297-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206297-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206297-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206297-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206297-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206297-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206297-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206297-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206297-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206297-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206297-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206297-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206297-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206297-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206297-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206297-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206297-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206297-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206297-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206297-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206297-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206297-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206297-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206297-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206297-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206297-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206297-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206297-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206297-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206297-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206297-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206297-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206297-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206297-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206297-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206297-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206297-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206297-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206297-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206297-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206297-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206297-001	AT	1	`f41ea6bd6efb…`

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: Lidocaine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1543069	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
f93cbde5-329a-f880-e053-6294a90a1af2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0324-1	Lidocaine	1 in 1 CARTON	OINTMENT	1		2
80425-0324-1	Lidocaine	35.44 g in 1 TUBE	OINTMENT	35.44		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0324-1	GM - Gram	80425-0324	3f0d4c80-6206-4cb8-b9e9-c79af547fa16	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0324	LIDOCAINE OINTMENT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 2 package rows	20250102_f93cbde5-329a-f880-e053-6294a90a1af2.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	960f6d0a-82af-45e9-89d5-cea808004ebb	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	4806f94d-cbac-4107-b93b-8f715868ffb3	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	PHOENIX RX LLC	40949067-a5a8-db8c-e063-6294a90af0fb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18b8413-8f52-a927-e053-2a95a90a402a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297 ndc (package): 80425-0324-1 ndc (product): 80425-0324 ndc11 (package): 80425032401
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6fe7721d-42b3-4284-936b-a448ca530c45	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	d1509740-f9f1-44e3-8fde-51d8683fcd87	2018-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297

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	f93cbde5-329a-f880-e053-6294a90a1af2	2
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	f93cbde5-329a-f880-e053-6294a90a1af2	2
1543069	lidocaine 5 % Topical Ointment	SY	f93cbde5-329a-f880-e053-6294a90a1af2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0324-1	80425032401	1 TUBE in 1 CARTON (80425-0324-1) / 35.44 g in 1 TUBE	1 tube	2023-04-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Ointment	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2