Lidocaine Hydrochloride

Product NDC
76329-3015
11-digit product format
763293015
Labeler code
76329
Product ID
76329-3015_483019ba-e338-42f2-82da-2401e40e417c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
International Medication Systems, Limited
Application
ANDA086283
Marketing category
ANDA
Marketing start
1979-08-07
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086283-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A086283-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086283-001LIDOCAINE HYDROCHLORIDE2%JELLY / TOPICALATApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A086283-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086283-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A086283-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086283-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086283-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086283-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086283-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086283-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086283-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086283-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086283-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086283-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086283-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086283-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086283-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086283-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086283-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086283-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086283-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086283-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086283-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A086283-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086283-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086283-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086283-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A086283-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A086283-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086283-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086283-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086283-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086283-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086283-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086283-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086283-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A086283-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A086283-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086283-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086283-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086283-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086283-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011852Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0cbc37d3-c2d6-4747-9834-7c23b38fcc20Available 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
76329-3015-5Lidocaine Hydrochloride20 mL in 1 VIAL, SINGLE-USEJELLY207
76329-3015-5Lidocaine Hydrochloride25 in 1 BOXJELLY257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-3015-5ML - Milliliter76329-30154c71482f-affa-4944-a1f5-9a15f651278612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3015LIDOCAINE HYDROCHLORIDE JELLY [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]7Current NDC, Legacy NDC, 2 package rows20240907_0cbc37d3-c2d6-4747-9834-7c23b38fcc20.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.f73d4546-c9ac-4155-8492-552d6ce70c842025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.f0617ab8-555f-4cbe-9795-c922f5ef176e2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEInternational Medication Systems, Limited0cbc37d3-c2d6-4747-9834-7c23b38fcc202024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283
ndc (product): 76329-3015
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4bf5905-add7-1cb0-e053-2995a90a73342024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4c0df51-cc37-323d-e053-2995a90a154a2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst95351883-ec37-f94a-e053-2995a90aa36a2024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086283
application number: ANDA086283

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN0cbc37d3-c2d6-4747-9834-7c23b38fcc207
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD0cbc37d3-c2d6-4747-9834-7c23b38fcc207
1011852lidocaine hydrochloride 2 % Topical JellySY0cbc37d3-c2d6-4747-9834-7c23b38fcc207
1011852lidocaine HCl 2 % Topical GelPSNddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c6
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c6
1011852lidocaine hydrochloride 2 % Topical JellySYddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c6
1011852lidocaine HCl 2 % Topical GelPSN7b80b072-b52f-43dc-8bc3-14a6d961244a3
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD7b80b072-b52f-43dc-8bc3-14a6d961244a3
1011852lidocaine hydrochloride 2 % Topical JellySY7b80b072-b52f-43dc-8bc3-14a6d961244a3
1011852lidocaine HCl 2 % Topical GelPSNc4bf5905-add7-1cb0-e053-2995a90a73342
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDc4bf5905-add7-1cb0-e053-2995a90a73342
1011852lidocaine hydrochloride 2 % Topical JellySYc4bf5905-add7-1cb0-e053-2995a90a73342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76329-3015-57632930150525 VIAL, SINGLE-USE in 1 BOX (76329-3015-5) / 20 mL in 1 VIAL, SINGLE-USE1979-08-070000-00-00NoNoCurrent