Lidocaine hydrochloride

Product NDC: 70518-4030
11-digit product format: 705184030
Labeler code: 70518
Product ID: 70518-4030_4e6515ec-ac0e-058c-e063-6394a90a4c45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine hydrochloride
Dosage form: SOLUTION
Route: ORAL; TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA216780
Marketing category: ANDA
Marketing start: 2024-02-29
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-4030-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-4030-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A216780-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216780-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2023-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2023-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2023-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2023-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2023-03-28	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216780-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	2023-03-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216780-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216780-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216780-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216780-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216780-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216780-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216780-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216780-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216780-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216780-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216780-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216780-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216780-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216780-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216780-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216780-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216780-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216780-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216780-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216780-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216780-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216780-001	AT	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216780-001	AT	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010739	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
adc4dd69-45f3-48fe-bf85-f014b384c38e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4030-0	Lidocaine hydrochloride	100 mL in 1 BOTTLE	SOLUTION	100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4030	LIDOCAINE HYDROCHLORIDE SOLUTION [REMEDYREPACK INC.]	1	Current NDC, 1 package rows	20240301_adc4dd69-45f3-48fe-bf85-f014b384c38e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	55aa77b8-7601-4432-8631-bfec58daf247	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	adc4dd69-45f3-48fe-bf85-f014b384c38e	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780 ndc (product): 70518-4030
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Advagen Pharma Ltd	ae40021b-8df8-4b16-aac0-dcec88f76c7d	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	e67dee40-b243-4d6b-bc6b-e52c6cb798b8	2025-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Atlantic Biologicals Corp.	401ecb6c-392b-1d74-e063-6294a90a4005	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	American Health Packaging	0a36a6de-40d5-41ba-bb5f-39d36c267b7f	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	75d17334-6876-42d0-8a02-82669d139e4f	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	037764d3-da0e-5ebb-e063-6294a90ab6e0	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216780 application number: ANDA216780

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010739	lidocaine HCl 2 % Mucous Membrane Topical Solution	PSN	adc4dd69-45f3-48fe-bf85-f014b384c38e	4
1010739	lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical Solution	SCD	adc4dd69-45f3-48fe-bf85-f014b384c38e	4
1010739	lidocaine HCl 2 % Oral Topical Solution	SY	adc4dd69-45f3-48fe-bf85-f014b384c38e	4
1010739	lidocaine HCl 2 % Oromucosal Solution	SY	adc4dd69-45f3-48fe-bf85-f014b384c38e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4030-0	70518403000	100 mL in 1 BOTTLE (70518-4030-0)	100 ml	2024-02-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous)	REMEDYREPACK INC.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	4