Xylocaine

Product NDC
76420-369
11-digit product format
764200369
Labeler code
76420
Product ID
76420-369_366ad8d7-33a0-b252-e063-6294a90a7a16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Asclemed USA, Inc.
Application
NDA006488
Marketing category
NDA
Marketing start
2010-08-12
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N006488-002XYLOCAINELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-003XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 1982
N006488-004XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-005XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 1982
N006488-007XYLOCAINELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-008XYLOCAINELIDOCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-010XYLOCAINELIDOCAINE HYDROCHLORIDE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-012XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-017XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-018XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-13
N006488-019XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-13

Therapeutic equivalence codes#

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

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

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 · 473 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-012XYLOCAINE W/ EPINEPHRINE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-017XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N006488-018XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-1384e616aacf4f…
2026-09-14 22:38:342026-08N006488-019XYLOCAINE W/ EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-1384e616aacf4f…
2026-08-18 06:07:402026-07N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-012XYLOCAINE W/ EPINEPHRINE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-017XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-018XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-019XYLOCAINE W/ EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-012XYLOCAINE W/ EPINEPHRINE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-017XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-018XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-019XYLOCAINE W/ EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 363 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N006488-002AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-004AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-007AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-008AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-010AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-012AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-017AP184e616aacf4f…
2026-09-14 22:38:342026-08N006488-019AP184e616aacf4f…
2026-08-18 06:07:402026-07N006488-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-007AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-008AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-010AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-012AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-017AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N006488-019AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N006488-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-007AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-008AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-010AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-012AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-017AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-019AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-007AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-008AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-010AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-012AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-017AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-019AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N006488-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-007AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-008AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-010AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-012AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-017AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-019AP16a471c1ec25d…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Xylocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EC2CNF7XFPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010671Internal RxNorm lookup
1010673Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25370b0f-0ac6-4a03-abe6-d73d65192180Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-369-10Xylocaine10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
76420-369-25Xylocaine25 in 1 TRAYINJECTION, SOLUTION251

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xylocaine MPFLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCfe265eb5-eaeb-4f47-82dd-238c1d53fec42024-03-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINELIDOCAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta0997348-6274-060a-e053-2a95a90abea72024-02-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINELIDOCAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09af094-7cfc-1d47-e053-2a95a90a6b692024-02-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirste3b3b462-8f35-68b8-e053-2995a90a64032024-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINE- MPF (LIDOCAINE HCl )LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste8b987c8-b5cb-74cd-e053-2a95a90a5a932024-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst971439ed-4507-7a30-e053-2a95a90a1f1c2024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINELIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst94e9f2db-af29-032e-e053-2995a90a7f7b2024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirst0c6c5678-e987-b822-e063-6394a90ac88b2024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEA-S Medication Solutions38610ee9-4e70-4a8a-a5c5-6c148cf145f02023-12-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010671lidocaine HCl 2 % Injectable SolutionPSN25370b0f-0ac6-4a03-abe6-d73d651921801
1010673Xylocaine 2 % Injectable SolutionPSN25370b0f-0ac6-4a03-abe6-d73d651921801
1010673lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine]SBD25370b0f-0ac6-4a03-abe6-d73d651921801
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD25370b0f-0ac6-4a03-abe6-d73d651921801
1010671lidocaine hydrochloride 2 % Injectable SolutionSY25370b0f-0ac6-4a03-abe6-d73d651921801
1010673Xylocaine 2 % Injectable SolutionSY25370b0f-0ac6-4a03-abe6-d73d651921801
1010673Xylocaine 20 MG/ML Injectable SolutionSY25370b0f-0ac6-4a03-abe6-d73d651921801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-369-107642003691010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
76420-369-257642003692525 VIAL, MULTI-DOSE in 1 TRAY (76420-369-25) / 10 mL in 1 VIAL, MULTI-DOSE (76420-369-10) 2025-05-31NoNoCurrent