LIDOCAINE AND PRILOCAINE

Product NDC
0574-2042
11-digit product format
005742042
Labeler code
0574
Product ID
0574-2042_8c1f8f53-eb32-4b0f-b6e7-98a2854fcbfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis US LLC
Application
ANDA212482
Marketing category
ANDA
Marketing start
2022-12-20
Substance
LIDOCAINE; PRILOCAINE
Active strength
25; 25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], 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
A212482-001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212482-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICAL2021-07-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212482-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2021-07-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212482-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212482-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212482-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212482-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212482-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212482-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212482-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212482-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212482-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212482-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212482-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212482-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212482-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212482-001AB18072bd15b7f6…
2021-12-28 21:50 UTC2021-12A212482-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212482-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212482-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212482-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212482-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212482-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212482-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212482-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212482-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212482-001AB13bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212482-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
LIDOCAINE AND PRILOCAINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE25 mg/g
PRILOCAINE25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
046O35D44RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197877Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e1635f7-dcae-441b-bbf7-495661fb66aeAvailable 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
0574-2042-30LIDOCAINE AND PRILOCAINE30 g in 1 TUBECREAM306
0574-2042-30LIDOCAINE AND PRILOCAINE1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-2042-30GM - Gram0574-2042a42f8ae6-75c8-4663-b931-25b9409d866512023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-2042LIDOCAINE AND PRILOCAINE CREAM [PADAGIS US LLC]4Current NDC, Legacy NDC, 2 package rows20230913_6e1635f7-dcae-441b-bbf7-495661fb66ae.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEPadagis US LLC6e1635f7-dcae-441b-bbf7-495661fb66ae2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
ndc (product): 0574-2042
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEPreferred Pharmaceuticals Inc.82111bef-460f-4948-a19c-1d2063427ee42026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack3cd9a055-8b9b-4dff-967b-54023df72e432025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack889a8ba8-4058-49e1-8b28-08a3afbf280f2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack5bee9fab-a493-448e-b68c-fb58156d49b62025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINENuCare Pharmaceuticals, Inc.365e59a2-b970-2ab1-e063-6294a90acfa92025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack2cd9f2a5-3726-4c74-b561-1555faf8ea882024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEA-S Medication Solutionsa4c310f5-e83e-4e40-a73d-818da5f49fec2023-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212482
application number: ANDA212482

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN2cd9f2a5-3726-4c74-b561-1555faf8ea88105
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD2cd9f2a5-3726-4c74-b561-1555faf8ea88105
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY2cd9f2a5-3726-4c74-b561-1555faf8ea88105
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN3cd9a055-8b9b-4dff-967b-54023df72e43104
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD3cd9a055-8b9b-4dff-967b-54023df72e43104
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY3cd9a055-8b9b-4dff-967b-54023df72e43104
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN889a8ba8-4058-49e1-8b28-08a3afbf280f100
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN5bee9fab-a493-448e-b68c-fb58156d49b6100
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD889a8ba8-4058-49e1-8b28-08a3afbf280f100
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD5bee9fab-a493-448e-b68c-fb58156d49b6100
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY889a8ba8-4058-49e1-8b28-08a3afbf280f100
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY5bee9fab-a493-448e-b68c-fb58156d49b6100
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN6e1635f7-dcae-441b-bbf7-495661fb66ae6
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD6e1635f7-dcae-441b-bbf7-495661fb66ae6
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY6e1635f7-dcae-441b-bbf7-495661fb66ae6
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN1a65c3ed-0a59-4454-9447-8bf761ed9f334
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD1a65c3ed-0a59-4454-9447-8bf761ed9f334
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY1a65c3ed-0a59-4454-9447-8bf761ed9f334
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN365e59a2-b970-2ab1-e063-6294a90acfa91
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN82111bef-460f-4948-a19c-1d2063427ee41
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSNa4c310f5-e83e-4e40-a73d-818da5f49fec1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD365e59a2-b970-2ab1-e063-6294a90acfa91
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD82111bef-460f-4948-a19c-1d2063427ee41
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCDa4c310f5-e83e-4e40-a73d-818da5f49fec1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY82111bef-460f-4948-a19c-1d2063427ee41
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY365e59a2-b970-2ab1-e063-6294a90acfa91
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSYa4c310f5-e83e-4e40-a73d-818da5f49fec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-2042-30005742042301 TUBE in 1 CARTON (0574-2042-30) / 30 g in 1 TUBE1 tube2022-12-200000-00-00NoNoCurrent