LIDOCAINE

Product NDC: 72189-168
Requested package NDC: 72189-168-50
11-digit product format: 721890168
Labeler code: 72189
Product ID: 72189-168_4d27e4f7-61ea-3c3e-e063-6394a90a3340
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: DIRECT RX
Application: ANDA207810
Marketing category: ANDA
Marketing start: 2021-01-12
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-168	72189-168-50	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A207810-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2017-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207810-001	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	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`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	A207810-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207810-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207810-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207810-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207810-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207810-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207810-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207810-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207810-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207810-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207810-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207810-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207810-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207810-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207810-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207810-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207810-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207810-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207810-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207810-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207810-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207810-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207810-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207810-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207810-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207810-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207810-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207810-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207810-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207810-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207810-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207810-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207810-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207810-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207810-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207810-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207810-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207810-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207810-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207810-001	AT	1	`cb3db0bc1861…`

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
b8663046-67a4-4858-e053-2a95a90a8aed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
72189-168-35	LIDOCAINE	35.44 g in 1 TUBE	OINTMENT	35.44		7
72189-168-50	LIDOCAINE	50 g in 1 TUBE	OINTMENT	50		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-168-35	GM - Gram	72189-168	691e596a-0c1f-480b-a33d-403078e57d16	1	2021-02-05
72189-168-50	GM - Gram	72189-168	9425f0fc-399e-4fa8-81f0-4d1304ba65ad	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-168	LIDOCAINE OINTMENT [DIRECT RX]	6	Current NDC, Legacy NDC, 2 package rows	20250119_b8663046-67a4-4858-e053-2a95a90a8aed.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE	LIDOCAINE	DIRECT RX	b8663046-67a4-4858-e053-2a95a90a8aed	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810 ndc (package): 72189-168-50 ndc (product): 72189-168 ndc11 (package): 72189016850
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	a134c265-4fb6-4c78-b9cc-fae8f1fff1cf	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	68bc320f-2871-45b9-815e-bb26081e8249	2023-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	da9707e2-f830-45e2-a300-1f99cf3dd362	2023-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810
Lidocaine	LIDOCAINE	Proficient Rx LP	2c396307-cf12-41d0-89e6-0f4ec74df55e	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810

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	b8663046-67a4-4858-e053-2a95a90a8aed	7
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	b8663046-67a4-4858-e053-2a95a90a8aed	7
1543069	lidocaine 5 % Topical Ointment	SY	b8663046-67a4-4858-e053-2a95a90a8aed	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-168-50	72189016850	50 g in 1 TUBE (72189-168-50)	50 g	2021-01-12	0000-00-00	No	No	Current