CURACAINE

Product NDC
51350-011
11-digit product format
513500011
Labeler code
51350
Product ID
51350-011_2e03cdce-9668-41b3-9d88-95cfa038f581
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
Transdermal Corp
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-03-03
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
4 g/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51350-011IInactivated by FDA2026-10-16
excluded packagepackage51350-01151350-011-51IInactivated by FDA2026-10-16

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51350-011-51IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51350-011-51IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51350-011-51IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51350-011-51IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51350-011-51IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51350-011-51IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51350-011-51IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51350-011-51IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51350-011-51IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51350-011-51IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51350-011-51IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51350-011-51IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51350-011-51IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51350-011-51IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51350-011-51IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51350-011-51IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51350-011-51IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51350-011-51IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51350-011-51IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51350-011-51IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51350-011-51IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51350-011-51EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51350-011-512020-01-31C16284748780-19d75b9d0-f544-f424-e053-dadaa90a57ce731c9dc1-9b77-4d10-9851-d35eb777f7cd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51350-011-01CURACAINE30 mL in 1 TUBECREAM302
51350-011-51CURACAINE1 in 1 BOXCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987CURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
LIDOCAINEACTIVE MOIETY98PI200987CURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RCURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51350-011CURACAINE (LIDOCAINE) CREAM [TRANSDERMAL CORP]2Legacy NDC, 2 package rows20150416_731c9dc1-9b77-4d10-9851-d35eb777f7cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421893lidocaine 4 % Topical CreamPSN731c9dc1-9b77-4d10-9851-d35eb777f7cd2
1421893lidocaine 40 MG/ML Topical CreamSCD731c9dc1-9b77-4d10-9851-d35eb777f7cd2
1421893lidocaine 4 % Topical CreamSY731c9dc1-9b77-4d10-9851-d35eb777f7cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51350-011-015135000110130 mL in 1 TUBE30 mlHistorical
51350-011-51513500011511 in 1 BOXHistorical