Lidocaine

Product NDC
0168-0204
Requested package NDC
0168-0204-37
11-digit product format
001680204
Labeler code
0168
Product ID
0168-0204_76e9f389-e9f0-4568-8b13-74c9dd831001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Fougera Pharmaceuticals, LLC
Application
ANDA080198
Marketing category
ANDA
Marketing start
1972-06-30
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
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0168-02040168-0204-37IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

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
A080198-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080198-001AT

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 06:07:402026-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved before 1982e64feba35796…

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 06:07:402026-07A080198-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080198-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080198-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080198-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080198-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080198-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080198-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080198-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080198-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080198-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080198-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080198-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080198-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080198-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080198-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080198-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080198-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080198-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080198-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080198-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080198-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080198-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A080198-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080198-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080198-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080198-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A080198-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080198-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080198-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080198-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080198-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080198-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080198-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080198-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080198-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080198-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080198-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080198-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080198-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080198-001AT1e64feba35796…

Additional Listing Data#

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

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
88ca9cba-0c4a-482f-b502-ceefdb1bfbcdAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-01-25LIDOCAINE OINTMENT USP, 5%
2020-09-27LIDOCAINE OINTMENT USP, 5%
2020-09-25LIDOCAINE OINTMENT USP, 5%
2020-07-22LIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0204-37Lidocaine35.44 g in 1 TUBEOINTMENT35.4411
0168-0204-37Lidocaine1 in 1 CARTONOINTMENT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0204-37GM - Gram0168-020435c62859-1d06-4f09-93c7-61d8ac84ca7812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0204LIDOCAINE OINTMENT [FOUGERA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20240601_88ca9cba-0c4a-482f-b502-ceefdb1bfbcd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEFougera Pharmaceuticals, LLC88ca9cba-0c4a-482f-b502-ceefdb1bfbcd2026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080198
application number: ANDA080198
ndc (package): 0168-0204-37
ndc (product): 0168-0204
ndc11 (package): 00168020437

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN88ca9cba-0c4a-482f-b502-ceefdb1bfbcd11
1543069lidocaine 0.05 MG/MG Topical OintmentSCD88ca9cba-0c4a-482f-b502-ceefdb1bfbcd11
1543069lidocaine 5 % Topical OintmentSY88ca9cba-0c4a-482f-b502-ceefdb1bfbcd11
1543069lidocaine 5 % Topical OintmentPSN670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 5 % Topical OintmentPSNa1e2c14f-0682-4b19-9159-de0aca1960c61
1543069lidocaine 0.05 MG/MG Topical OintmentSCD670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCDa1e2c14f-0682-4b19-9159-de0aca1960c61
1543069lidocaine 5 % Topical OintmentSY670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 5 % Topical OintmentSYa1e2c14f-0682-4b19-9159-de0aca1960c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0204-37001680204371 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE1 tube1972-06-300000-00-00NoNoCurrent