Lidocaine

Product NDC
65162-918
11-digit product format
651620918
Labeler code
65162
Product ID
65162-918_1f3288ac-58b0-4278-aed2-51cc99724d9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA206297
Marketing category
ANDA
Marketing start
2015-08-10
Substance
LIDOCAINE
Active strength
50 mg/g
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 42.

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
A206297-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206297-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206297-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206297-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206297-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206297-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206297-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206297-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206297-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206297-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206297-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206297-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206297-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206297-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206297-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206297-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206297-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206297-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206297-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206297-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206297-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206297-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206297-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206297-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A206297-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206297-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206297-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206297-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206297-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206297-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206297-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206297-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206297-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206297-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206297-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206297-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206297-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206297-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206297-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206297-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206297-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206297-001AT1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1543069Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1509740-f9f1-44e3-8fde-51d8683fcd87Available 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
65162-918-30Lidocaine30 g in 1 TUBEOINTMENT3022
65162-918-30Lidocaine1 in 1 CARTONOINTMENT122
65162-918-38Lidocaine1 in 1 CARTONOINTMENT122
65162-918-38Lidocaine35.44 g in 1 TUBEOINTMENT35.4422
65162-918-53Lidocaine50 g in 1 JAROINTMENT5022
65162-918-41Lidocaine150 g in 1 JAROINTMENT15010
65162-918-45Lidocaine250 g in 1 JAROINTMENT25010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-918-38GM - Gram65162-9188230b9f9-3f32-4a90-85e9-206c918005e012015-11-12
65162-918-41GM - Gram65162-918bfa0e4e5-bafc-4485-861b-b70bbe8da3d912017-07-07
65162-918-45GM - Gram65162-91826929407-0f83-4b0b-8ae6-bab1f98e158712017-07-07
65162-918-53GM - Gram65162-9186770a7f2-7d8a-4c05-a329-c8e7accb446312015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-918LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS LLC]22Current NDC, Legacy NDC, 5 package rows20241030_d1509740-f9f1-44e3-8fde-51d8683fcd87.zip
65162-918LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 2 package rows20241030_960f6d0a-82af-45e9-89d5-cea808004ebb.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
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
ndc (product): 65162-918
LidocaineLIDOCAINEPreferred Pharmaceuticals Inc.4806f94d-cbac-4107-b93b-8f715868ffb32026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEPHOENIX RX LLC40949067-a5a8-db8c-e063-6294a90af0fb2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf18b8413-8f52-a927-e053-2a95a90a402a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf93cbde5-329a-f880-e053-6294a90a1af22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEBryant Ranch Prepack6fe7721d-42b3-4284-936b-a448ca530c452023-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAmneal Pharmaceuticals LLCd1509740-f9f1-44e3-8fde-51d8683fcd872018-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
ndc (product): 65162-918

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN6fe7721d-42b3-4284-936b-a448ca530c45100
1543069lidocaine 0.05 MG/MG Topical OintmentSCD6fe7721d-42b3-4284-936b-a448ca530c45100
1543069lidocaine 5 % Topical OintmentSY6fe7721d-42b3-4284-936b-a448ca530c45100
1543069lidocaine 5 % Topical OintmentPSNd1509740-f9f1-44e3-8fde-51d8683fcd8722
1543069lidocaine 0.05 MG/MG Topical OintmentSCDd1509740-f9f1-44e3-8fde-51d8683fcd8722
1543069lidocaine 5 % Topical OintmentSYd1509740-f9f1-44e3-8fde-51d8683fcd8722
1543069lidocaine 5 % Topical OintmentPSN4806f94d-cbac-4107-b93b-8f715868ffb311
1543069lidocaine 0.05 MG/MG Topical OintmentSCD4806f94d-cbac-4107-b93b-8f715868ffb311
1543069lidocaine 5 % Topical OintmentSY4806f94d-cbac-4107-b93b-8f715868ffb311
1543069lidocaine 5 % Topical OintmentPSN960f6d0a-82af-45e9-89d5-cea808004ebb10
1543069lidocaine 0.05 MG/MG Topical OintmentSCD960f6d0a-82af-45e9-89d5-cea808004ebb10
1543069lidocaine 5 % Topical OintmentSY960f6d0a-82af-45e9-89d5-cea808004ebb10
1543069lidocaine 5 % Topical OintmentPSNf18b8413-8f52-a927-e053-2a95a90a402a3
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf18b8413-8f52-a927-e053-2a95a90a402a3
1543069lidocaine 5 % Topical OintmentSYf18b8413-8f52-a927-e053-2a95a90a402a3
1543069lidocaine 5 % Topical OintmentPSN51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentPSNf93cbde5-329a-f880-e053-6294a90a1af22
1543069lidocaine 5 % Topical OintmentPSN40949067-a5a8-db8c-e063-6294a90af0fb2
1543069lidocaine 0.05 MG/MG Topical OintmentSCD40949067-a5a8-db8c-e063-6294a90af0fb2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf93cbde5-329a-f880-e053-6294a90a1af22
1543069lidocaine 0.05 MG/MG Topical OintmentSCD51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentSYf93cbde5-329a-f880-e053-6294a90a1af22
1543069lidocaine 5 % Topical OintmentSY51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentSY40949067-a5a8-db8c-e063-6294a90af0fb2
1543069lidocaine 5 % Topical OintmentPSN9addc699-fd91-9c84-e053-2995a90aff471
1543069lidocaine 0.05 MG/MG Topical OintmentSCD9addc699-fd91-9c84-e053-2995a90aff471
1543069lidocaine 5 % Topical OintmentSY9addc699-fd91-9c84-e053-2995a90aff471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-918-30651620918301 TUBE in 1 CARTON (65162-918-30) / 30 g in 1 TUBE1 tube2015-08-100000-00-00NoNoCurrent
65162-918-38651620918381 TUBE in 1 CARTON (65162-918-38) / 35.44 g in 1 TUBE1 tube2015-08-100000-00-00NoNoCurrent
65162-918-4165162091841150 g in 1 JAR (65162-918-41) 150 g2015-08-100000-00-00NoNoCurrent
65162-918-4565162091845250 g in 1 JAR (65162-918-45) 250 g2015-08-100000-00-00NoNoCurrent
65162-918-536516209185350 g in 1 JAR (65162-918-53) 50 g2015-08-100000-00-00NoNoCurrent