Lidocaine

Product NDC
0168-0204
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

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
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 · 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 UTC2026-02A080198-001LIDOCAINE5%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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080198-001LIDOCAINE5%OINTMENT / TOPICALATRLD, RS, Approved 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 UTC2026-02A080198-001AT1011fe1cb6892…
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080198-001AT1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 0168-0204

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#

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

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