Xylocaine

Product NDC: 70518-4152
Requested package NDC: 70518-4152-1
11-digit product format: 705184152
Labeler code: 70518
Product ID: 70518-4152_40bbf18f-8948-ef62-e063-6394a90aa2d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: REMEDYREPACK INC.
Application: NDA006488
Marketing category: NDA
Marketing start: 2024-07-31
Substance: EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength: .01; 10 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-4152	70518-4152-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N006488-002	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-003	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982
N006488-004	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-005	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N006488-007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-008	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-010	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-012	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-017	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-018	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13
N006488-019	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N006488-002	AP
N006488-004	AP
N006488-007	AP
N006488-008	AP
N006488-010	AP
N006488-012	AP
N006488-017	AP
N006488-019	AP

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 12 · 451 observed 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	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 347 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	N006488-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-012	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-017	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-019	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-012	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-017	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-019	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006488-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-012	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-017	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-019	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-010	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-012	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-017	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-019	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-008	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-010	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-012	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-017	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-019	AP	1	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Xylocaine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS	.01 mg/mL
EPINEPHRINE BITARTRATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EC2CNF7XFP	Internal UNII lookup
30Q7KI53AK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010751	Internal RxNorm lookup
1010755	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
1414bcfc-1543-4ad4-83bd-4fc444a02e92	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
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-4152-0	Xylocaine	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	5
70518-4152-1	Xylocaine	25 in 1 TRAY	INJECTION, SOLUTION	25	5
70518-4152-2	Xylocaine	25 in 1 TRAY	INJECTION, SOLUTION	25	5
70518-4152-3	Xylocaine	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4152	XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [REMEDYREPACK INC.]	2	Current NDC, 4 package rows	20250116_1414bcfc-1543-4ad4-83bd-4fc444a02e92.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	50aa6133-0776-4714-9821-fe8581f635ca	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE-MPF WITH EPI	XYLOCAINE-MPF WITH EPI	HF Acquisition Co LLC, DBA HealthFirst	c5dcb0e5-2624-9c9c-e053-2995a90a6d65	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Sportpharm LLC	74bad838-2800-4d36-a3ee-cc1d739d24c2	2026-03-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	94155012-b1fc-430a-a1f5-30c21f4a3f80	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	27c2e78d-d037-470d-b4fa-44c33d78f788	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	6899113c-dee4-4227-9f68-475fcce6b91e	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	cfcc8a07-b40c-476d-9a21-83487318ac85	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ffc87dfb-0e26-4b42-80fd-3fb7690119e3	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HCL	Henry Schein, Inc.	a6019956-a6e0-4988-a870-6aee06c354c3	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	REMEDYREPACK INC.	1414bcfc-1543-4ad4-83bd-4fc444a02e92	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (package): 70518-4152-1 ndc (product): 70518-4152 ndc11 (package): 70518415201
Xylocaine	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION	Henry Schein, Inc	9e8d0318-b2fe-4084-aedf-de97f61605a8	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	ProPharma Distribution	386c23fd-1691-98b2-e063-6294a90ab070	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	25370b0f-0ac6-4a03-abe6-d73d65192180	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAIN (LIDOCAINE HCl )	XYLOCAINE (LIDOCAINE HCL )	HF Acquisition Co LLC, DBA HealthFirst	e1838a93-7f2a-14f1-e053-2a95a90a8d69	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	4dd52202-8eef-4136-92dd-ada573b7cf74	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	1986c302-82a0-95a9-e063-6294a90a3339	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	199ac3eb-1fa5-9cf5-e063-6394a90a7228	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	17e77013-f2a0-b1f7-e063-6294a90ae468	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE MPF	XYLOCAINE MPF	HF Acquisition Co LLC, DBA HealthFirst	18705416-9593-43f2-e063-6294a90a31b4	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	d5e0d06f-ba1e-44d4-aa89-39d6c146dc23	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010751	lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010755	Xylocaine 1 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010755	epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine with Epinephrine]	SBD	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010751	epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution	SCD	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010751	epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable Solution	SY	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010751	lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution	SY	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010755	Xylocaine 1 % with epinephrine 1:100,000 Injectable Solution	SY	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5
1010755	Xylocaine with Epinephrine 1/1:100,000 (lidocaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable Solution	SY	1414bcfc-1543-4ad4-83bd-4fc444a02e92	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4152-1	70518415201	25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-1) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4152-0)	2024-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)	REMEDYREPACK INC.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	5