lidocaine

Manufacturer: Central Packaging | Central Packaging, LLC
Effective date: 2021-02-23
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:35:41

Label at a glance#

Productlidocaine

Active ingredientLIDOCAINE

Label structure3 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

CONTRAINDICATIONS SECTION

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment USP, 5%.

Frame Style Transparent Dressing are contraindicated as a primary dressing on moderately to heavily draining wounds. Avoid repeated applications on patients with thin or fragile skin that may result in skin damage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lidocaine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1543069	lidocaine 5 % Topical Ointment	PSN	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	1
1543069	lidocaine 5 % Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80175-0008-5	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
80175-0008	LIDOCAINE OINTMENT [CENTRAL PACKAGING]	1	Legacy NDC, 1 package rows	20210225_bc028dba-b823-0eeb-e053-2a95a90a7905.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-008-14	GM - Gram	52565-008	cee9d3df-bb17-401e-adfb-1a30da691891	1	2016-04-04
52565-008-55	GM - Gram	52565-008	d1aff958-0052-4ed8-9e28-b35a2e4603dd	1	2017-10-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

lidocaine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80175-0008	80175-0008-5
52565-008

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE	98PI200987	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A205318-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205318-001	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	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`f41ea6bd6efb…`

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	A205318-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205318-001	AT	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205318-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205318-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205318-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205318-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205318-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205318-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205318-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205318-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205318-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205318-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205318-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205318-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205318-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A205318-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205318-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205318-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205318-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205318-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205318-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205318-001	AT	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bc028dba-b824-0eeb-e053-2a95a90a7905			bc028dba-b823-0eeb-e053-2a95a90a7905	2021-02-23		Exact identifier spl id: bc028dba-b824-0eeb-e053-2a95a90a7905 spl set id: bc028dba-b823-0eeb-e053-2a95a90a7905

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.