Lidocaine

Product NDC: 50090-8040
11-digit product format: 500908040
Labeler code: 50090
Product ID: 50090-8040_5fe4bf4a-35f4-4897-b0da-39e54d700265
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA212695
Marketing category: ANDA
Marketing start: 2021-04-20
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: 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
A212695-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2021-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212695-001	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.

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	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212695-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212695-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212695-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212695-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212695-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212695-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212695-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212695-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212695-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212695-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212695-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212695-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212695-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212695-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212695-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212695-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212695-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212695-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212695-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212695-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212695-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212695-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212695-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212695-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212695-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212695-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212695-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212695-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212695-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212695-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212695-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212695-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212695-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212695-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212695-001	AT	1	`a50c72e98297…`

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: 2027-12-31

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
3fbe48b5-128a-471c-8ecb-45e903b56740	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	A-S Medication Solutions	3fbe48b5-128a-471c-8ecb-45e903b56740	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695 ndc (product): 50090-8040
Lidocaine	LIDOCAINE	Direct_rx	29f211ff-dcba-afb0-e063-6294a90afb9b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e679a0d-df82-435f-ad46-c871f3c76dfb	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	015cea25-d323-43dd-a92f-593a8e4a2921	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	325ddb61-84f5-075c-e063-6294a90ad5e9	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	QUAGEN PHARMACEUTICALS LLC	f8789807-cc0c-485c-aa98-1bdc39337deb	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8040-0	50090804000	1 TUBE in 1 CARTON (50090-8040-0) / 35.44 g in 1 TUBE	1 tube	2026-08-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only	A-S Medication Solutions	2026-08-28	HUMAN PRESCRIPTION DRUG LABEL	1