Lidocaine

Product NDC: 68788-4050
11-digit product format: 687884050
Labeler code: 68788
Product ID: 68788-4050_851844f5-912d-4598-84f3-c0277968b5f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA086724
Marketing category: ANDA
Marketing start: 2025-11-17
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 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
A086724-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086724-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`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	A086724-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086724-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086724-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086724-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086724-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086724-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086724-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086724-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086724-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086724-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086724-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086724-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086724-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086724-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086724-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086724-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086724-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086724-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086724-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086724-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086724-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086724-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086724-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086724-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086724-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086724-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086724-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086724-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086724-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086724-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086724-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086724-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086724-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086724-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086724-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086724-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086724-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086724-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086724-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086724-001	AT	1	`cb3db0bc1861…`

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
851844f5-912d-4598-84f3-c0277968b5f1	Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-4050-5	Lidocaine	1 in 1 CARTON	OINTMENT	1		1
68788-4050-5	Lidocaine	50 g in 1 JAR	OINTMENT	50		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-4050-5	GM - Gram	68788-4050	d2506ba9-bc9c-453f-9c0e-1d00c2d36751	1	2026-01-08

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	A-S Medication Solutions	2bb5b298-3802-446c-b8cd-313e84bff04e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Sun Pharmaceutical Industries, Inc.	5eb2c62f-5352-41d7-bd66-c65b1988a9ab	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
LIDOCAINE	LIDOCAINE	DIRECT RX	b8663046-67a4-4858-e053-2a95a90a8aed	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	851844f5-912d-4598-84f3-c0277968b5f1	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 68788-4050
Lidocaine	LIDOCAINE	PHOENIX RX LLC	3ff29d56-8f20-6376-e063-6294a90a667b	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	3a9a6630-e470-b794-e063-6394a90aaab5	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Golden State Medical Supply, Inc.	b948d6fe-3893-39a1-e053-2995a90ae64c	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Sun Pharmaceutical Industries, Inc.	ae758020-a508-4a2e-8164-e6c324e826a3	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	ATLANTIC BIOLOGICALS CORP.	1e8239f6-8d53-4b04-8bf8-c2cefe3ab5c3	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	NuCare Pharmaceuticals, Inc.	2e0f4ca3-874a-f0d0-e063-6294a90a0b65	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Quality Care Products, LLC	7bb5c092-91da-4789-b348-58548703d716	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Proficient Rx LP	f1007717-528a-42e2-94aa-db0edf3bb603	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724

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	851844f5-912d-4598-84f3-c0277968b5f1	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	851844f5-912d-4598-84f3-c0277968b5f1	1
1543069	lidocaine 5 % Topical Ointment	SY	851844f5-912d-4598-84f3-c0277968b5f1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4050-5	68788405005	1 JAR in 1 CARTON (68788-4050-5) / 50 g in 1 JAR	1 jar	2025-11-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE OINTMENT USP, 5% (Spearmint Flavored)	Preferred Pharmaceuticals Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	1