Xylocaine

Product NDC: 63323-485
Requested package NDC: 63323-485-27
11-digit product format: 633230485
Labeler code: 63323
Product ID: 63323-485_0ff12fe1-0ad7-4ae0-83bf-30f11e3adb33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: Fresenius Kabi USA, LLC
Application: NDA006488
Marketing category: NDA
Marketing start: 2010-08-12
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength: 10 mg/mL
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 · 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	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 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010033	Internal RxNorm lookup
1010035	Internal RxNorm lookup
1010671	Internal RxNorm lookup
1010673	Internal RxNorm lookup
1010751	Internal RxNorm lookup
1010755	Internal RxNorm lookup
1737562	Internal RxNorm lookup
1737563	Internal RxNorm lookup
1737566	Internal RxNorm lookup
1737567	Internal RxNorm lookup
1737568	Internal RxNorm lookup
1737569	Internal RxNorm lookup
1737570	Internal RxNorm lookup
1737571	Internal RxNorm lookup
1737757	Internal RxNorm lookup
1737758	Internal RxNorm lookup
1737761	Internal RxNorm lookup
1737762	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
4dd52202-8eef-4136-92dd-ada573b7cf74	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
63323-485-01	Xylocaine	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	13
63323-485-03	Xylocaine	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	13
63323-485-27	Xylocaine	25 in 1 TRAY	INJECTION, SOLUTION	25	13
63323-485-57	Xylocaine	25 in 1 TRAY	INJECTION, SOLUTION	25	13
63323-485-26	Xylocaine	25 in 1 TRAY	INJECTION, SOLUTION	25	7
63323-485-41	Xylocaine	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-485-01	ML - Milliliter	63323-485	55c3520d-d402-4267-87fe-ec239a7384ea	1	2019-12-10
63323-485-03	ML - Milliliter	63323-485	8152cfd7-4dd8-49cd-8f86-c8e56a346d48	1	2019-12-10
63323-485-26	ML - Milliliter	63323-485	2b9ff4f4-641e-4bb5-9378-b0f143bdac48	1	2016-09-02
63323-485-27	ML - Milliliter	63323-485	84d0434d-5c06-4795-baaa-4cf67cf1a8e9	1	2012-07-24
63323-485-41	ML - Milliliter	63323-485	7ad5e0f1-7fc8-4e2c-949a-b8a6bf1a6808	1	2020-07-13
63323-485-57	ML - Milliliter	63323-485	fcef2f79-20f4-4731-a3c6-7c153a2919bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
LIDOCAINE	ACTIVE MOIETY	98PI200987	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARDINAL HEALTH]	4
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]	1
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	XYLOCAINE (LIDOCAINE HYDROCHLORIDE ) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Lidocaine	ACTIVE MOIETY	98PI200987	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]	1
Lidocaine	ACTIVE MOIETY	98PI200987	XYLOCAINE (LIDOCAINE HYDROCHLORIDE ) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-485	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	13	Current NDC, Legacy NDC, 4 package rows	20210831_ba082c2f-64f4-419d-9c88-74f203316e17.zip
63323-485	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250515_4dd52202-8eef-4136-92dd-ada573b7cf74.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
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 ndc (product): 63323-485
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
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010745	lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737343	lidocaine HCl 0.5 % in 50 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010900	lidocaine HCl 0.5 % Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010751	lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867938	lidocaine HCl 1 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867943	lidocaine HCl 1 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737570	lidocaine HCl 1 % in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737568	lidocaine HCl 1 % in 2 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737562	lidocaine HCl 1 % in 30 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737566	lidocaine HCl 1 % in 5 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010033	lidocaine HCl 1 % Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867992	lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867996	lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010759	lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1868028	lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010688	lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737757	lidocaine HCl 2 % in 2 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737761	lidocaine HCl 2 % in 5 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010671	lidocaine HCl 2 % Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010749	Xylocaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737345	Xylocaine 0.5 % in 50 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010902	Xylocaine 0.5 % Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010755	Xylocaine 1 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867940	Xylocaine 1 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867944	Xylocaine 1 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737571	Xylocaine 1 % in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737569	Xylocaine 1 % in 2 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737563	Xylocaine 1 % in 30 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737567	Xylocaine 1 % in 5 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010035	Xylocaine 1 % Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867993	Xylocaine 1.5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867997	Xylocaine 1.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010763	Xylocaine 2 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1868029	Xylocaine 2 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010692	Xylocaine 2 % / EPINEPHrine 1:200,000 in 20 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737758	Xylocaine 2 % in 2 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737762	Xylocaine 2 % in 5 ML Injection	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010673	Xylocaine 2 % Injectable Solution	PSN	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867940	10 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML Injection [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867993	10 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1868029	10 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737571	10 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737569	2 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737758	2 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010692	20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867944	30 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML Injection [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867997	30 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737563	30 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737567	5 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737762	5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737345	50 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010749	epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010755	epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010763	epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine with Epinephrine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010035	lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010673	lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010902	lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]	SBD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867938	10 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867992	10 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1868028	10 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737570	10 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737568	2 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737757	2 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010688	20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867943	30 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1867996	30 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737562	30 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737566	5 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737343	50 ML lidocaine hydrochloride 5 MG/ML Injection	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010745	epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010751	epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010759	epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable Solution	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010033	lidocaine hydrochloride 10 MG/ML Injectable Solution	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010671	lidocaine hydrochloride 20 MG/ML Injectable Solution	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1010900	lidocaine hydrochloride 5 MG/ML Injectable Solution	SCD	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737571	10 ML Xylocaine 10 MG/ML Injection	SY	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737569	2 ML Xylocaine 10 MG/ML Injection	SY	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737758	2 ML Xylocaine 20 MG/ML Injection	SY	ba082c2f-64f4-419d-9c88-74f203316e17	13
1737563	30 ML Xylocaine 10 MG/ML Injection	SY	ba082c2f-64f4-419d-9c88-74f203316e17	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-485-27	63323048527	25 VIAL, MULTI-DOSE in 1 TRAY (63323-485-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-485-01)	2010-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xylocaine 1% (10mg/mL)	Henry Schein, Inc.	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	6
XYLOCAINE® (LIDOCAINE HCl INJECTION, USP) 1% 500 mg/50 mL (10 mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2025-05-07	HUMAN PRESCRIPTION DRUG LABEL	4
Xylocaine ® Xylocaine ® (lidocaine HCl Injection, USP) Xylocaine ® (lidocaine HCl and epinephrine Injection, USP)	Fresenius Kabi USA, LLC	2025-04-22	HUMAN PRESCRIPTION DRUG LABEL	7
Xylocaine Hydrochloride	HF Acquisition Co LLC, DBA HealthFirst	2024-01-27	HUMAN PRESCRIPTION DRUG LABEL	5
XYLOCAINE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Xylocaine 1% (10mg/mL)	General Injectables and Vaccines, inc.	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	8
Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)	Fresenius Kabi USA, LLC \| Fresenius Kabi Austria	2021-08-25	HUMAN PRESCRIPTION DRUG LABEL	13
Xylocaine	Cardinal Health	2020-06-08	HUMAN PRESCRIPTION DRUG LABEL	5
Xylocaine	Cardinal Health	2019-09-09	HUMAN PRESCRIPTION DRUG LABEL	7
Xylocaine	REMEDYREPACK INC.	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	1
Xylocaine	Physicians Total Care, Inc.	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	2
Xylocaine 1% (10mg/mL)	General Injectables & Vaccines, Inc	2011-09-26	HUMAN PRESCRIPTION DRUG LABEL	1